Advanced Idiopathic Parkinson's Disease
Conditions
Keywords
Health economics,Quality of life
Brief summary
The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.
Interventions
DEVICEpercutaneous endoscopic gastrostomy tube (PEG tube)
DEVICEjejunal extension tube (J-tube)
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
\- Advanced idiopathic Parkinson's disease
Exclusion criteria
\- Other diseases which might influence compliance or participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Direct Monthly Non-medical Costs Per Participant, SEK 2010 | Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants | Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK. |
| Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010 | Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants | Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK. |
| Monthly Drug Costs Per Participant, SEK 2010 | Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants | Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK. |
| Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010 | Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants | Total monthly costs include * Direct medical costs (inpatient care, outpatient care, and drug costs \[including Duodopa cost and cost of concomitant anti-PD medication\]). * Direct non-medical costs (nursing home, home help, personal assistance, informal care \[from family member or friend\] and transportation to inpatient, outpatient visits and nursing home). * Indirect costs (sick-leave and early retirement due to PD \[applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden\]). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK. |
| EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 | Baseline (Month -3), Month 12 | The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Baseline (Month -3), Month 12 | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability. |
| Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 | Baseline (Month -3), Month 12 | The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). |
| Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36 | Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Self-assessment' scores were -3 (Off) to +3 (dyskinetic). 'Off' time is when PD symptoms are not adequately controlled by the drug. 'Dyskinetic' time is time with involuntary muscle movement. 0 is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to 0 means improvement, everything more away from 0 means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score). |
| Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed' is a count of the number of taps per 20 seconds. |
| Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Free tapping' is defined as \_\_\_\_. 'Free tapping accuracy' is the percentage of accurate free taps per 20 seconds(?). |
| Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Tapping at increased speed - accuracy' is the percentage of accurate taps per all taps on computer-generated fields. |
| Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. |
| Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. 'Tapping random chase - accuracy' is the percentage of accurate random chase taps. |
| Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best. |
| Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Off time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day. |
| Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. On time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last \_\_ hours. |
| Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement, and is represented as a percentage of total time of the last \_\_ hours. |
| Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Off time' is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best). |
| Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best). |
| Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Cramps' scores were 1 (worst) to 5 (best). |
| Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Satisfied with function' scores were 1 (worst) to 5 (best). |
| Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided. |
| Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided. |
| Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided. |
| Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Schwab and England scale was used to rate the subject's best on period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). On time is when PD symptoms are well controlled by the drug. |
| Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early) | The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function. |
| MMSE Orientation Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function. |
| MMSE Registration Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function. |
| MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function. |
| MMSE Recall Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function. |
| MMSE Language Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function. |
| Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed). |
| MADRS Reported Sadness Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope. |
| MADRS Apparent Sadness Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture. |
| MADRS Inner Tension Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish. |
| MADRS Reduced Sleep Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well. |
| MADRS Reduced Appetite Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat. |
| MADRS Concentration Difficulties Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration. |
| MADRS Lassitude Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities. |
| MADRS Inability to Feel Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced. |
| MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin. |
| MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide. |
| Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms. |
| PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness. |
| Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best). |
Other
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' |
| EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement. |
| UPDRS Part IV Score, up to Month 36 | Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability. |
| UPDRS Part III Score, up to Month 36 | Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability. |
| UPDRS Part II Score, up to Month 36 | Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability. |
| UPDRS Part I Score, up to Month 36 | Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability. |
| UPDRS Total Score up to Month 36 | Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant) | The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duodopa Naïve Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. | 27 |
| Duodopa Non-naïve < 2 Years Duodopa non-naïve participants treated with Duodopa for \< 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. | 22 |
| Duodopa Non-naïve ≥ 2 Years Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL \[100-200 mg levodopa\]); the continuous maintenance dose (usually 2-6 mL/hour \[40-120 mg levodopa/hour\]); and extra bolus doses, adjusted individually. | 18 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 5 | 2 |
| Overall Study | Lack of Efficacy | 5 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 |
| Overall Study | Withdrew Consent Prior to Treatment | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Duodopa Naïve | Duodopa Non-naïve < 2 Years | Duodopa Non-naïve ≥ 2 Years | Total |
|---|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 6.4 | 65.4 years STANDARD_DEVIATION 5.2 | 66.6 years STANDARD_DEVIATION 8.7 | 65.4 years STANDARD_DEVIATION 6.8 |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 6 Participants | 24 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 12 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 29 / 36 | 22 / 22 | 17 / 18 |
| serious Total, serious adverse events | 24 / 36 | 17 / 22 | 14 / 18 |
Outcome results
Primary
Direct Monthly Non-medical Costs Per Participant, SEK 2010
Direct non-medical costs include nursing home, home help, personal assistance, informal care (from family member or friend) and transportation to inpatient, outpatient visits and nursing home. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.
Time frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duodopa Naïve | Direct Monthly Non-medical Costs Per Participant, SEK 2010 | 19274 SEK 2010 | Standard Deviation 26485 |
| Duodopa Non-naïve < 2 Years | Direct Monthly Non-medical Costs Per Participant, SEK 2010 | 27439 SEK 2010 | Standard Deviation 61656 |
| Duodopa Non-naïve ≥ 2 Years | Direct Monthly Non-medical Costs Per Participant, SEK 2010 | 25008 SEK 2010 | Standard Deviation 42455 |
| Total | Direct Monthly Non-medical Costs Per Participant, SEK 2010 | 23398 SEK 2010 | Standard Deviation 44698 |
Primary
EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state.
Time frame: Baseline (Month -3), Month 12
Population: Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 | Baseline (Month -3); n=27, 0, 0 | 0.44 units on a scale | Standard Deviation 0.2 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 | Month 12; n=25, 19, 17 | 0.63 units on a scale | Standard Deviation 0.18 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 | Month 12; n=25, 19, 17 | 0.64 units on a scale | Standard Deviation 0.19 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score at Baseline and Month 12 | Month 12; n=25, 19, 17 | 0.64 units on a scale | Standard Deviation 0.22 |
Comparison: Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)p-value: 0.002Wilcoxon tests
Primary
Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12
The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state).
Time frame: Baseline (Month -3), Month 12
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 | Baseline (Month -3); n=27, 0, 0 | 0.57 units on a scale | Standard Deviation 0.26 |
| Duodopa Naïve | Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 | Month 12; n=25, 20, 17 | 0.59 units on a scale | Standard Deviation 0.33 |
| Duodopa Non-naïve < 2 Years | Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 | Month 12; n=25, 20, 17 | 0.66 units on a scale | Standard Deviation 0.36 |
| Duodopa Non-naïve ≥ 2 Years | Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Euro QoL 5 Dimensions Quality of Life Instrument (EQ-5D) Descriptive Systems Summary Index Score at Baseline and Month 12 | Month 12; n=25, 20, 17 | 0.51 units on a scale | Standard Deviation 0.37 |
Comparison: Change from Baseline for the Duodopa Naïve group at Month 12 (n=25)p-value: 0.919Wilcoxon tests
Primary
Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010
Indirect costs consist of sick-leave and early retirement due to PD, are applied to individuals only up to the age of 65 since the main indirect cost item - early retirement due to disability - is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.
Time frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until Month 36
Population: All participants; n=fraction of number of participants younger than 65 years with indirect costs / number of participants assessed at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month -3; n=15/37 | 17032 SEK 2010 | Standard Deviation 20911 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 0; n=23/67 | 14109 SEK 2010 | Standard Deviation 19823 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 1; n=23/67 | 14109 SEK 2010 | Standard Deviation 19823 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 2; n=22/65 | 13896 SEK 2010 | Standard Deviation 19746 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 3; n=23/65 | 14543 SEK 2010 | Standard Deviation 19971 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 4; n=23/65 | 14543 SEK 2010 | Standard Deviation 19971 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 5; n=22/65 | 13896 SEK 2010 | Standard Deviation 19746 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 6; n=21/65 | 13250 SEK 2010 | Standard Deviation 19498 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 7; n=24/65 | 15512 SEK 2010 | Standard Deviation 20433 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 8; n=24/63 | 16005 SEK 2010 | Standard Deviation 20566 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 9; n=22/62 | 14569 SEK 2010 | Standard Deviation 19978 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 10; n=22/62 | 14569 SEK 2010 | Standard Deviation 19978 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 11; n=22/62 | 14399 SEK 2010 | Standard Deviation 19785 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 12; n=22/62 | 14399 SEK 2010 | Standard Deviation 19785 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 13; n=22/62 | 14230 SEK 2010 | Standard Deviation 19681 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 14; n=22/62 | 14569 SEK 2010 | Standard Deviation 19978 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 15; n=22/61 | 14808 SEK 2010 | Standard Deviation 20055 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 16; n=22/61 | 14808 SEK 2010 | Standard Deviation 20055 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 17; n=22/61 | 14463 SEK 2010 | Standard Deviation 19758 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 18; n=22/61 | 14463 SEK 2010 | Standard Deviation 19758 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 19; n=22/60 | 14704 SEK 2010 | Standard Deviation 19834 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 20; n=20/59 | 13529 SEK 2010 | Standard Deviation 19411 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 21; n=20/58 | 13763 SEK 2010 | Standard Deviation 19497 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 22; n=18/57 | 12530 SEK 2010 | Standard Deviation 18980 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 23; n=18/57 | 12530 SEK 2010 | Standard Deviation 18980 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 24; n=17/56 | 12003 SEK 2010 | Standard Deviation 18727 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 25; n=16/54 | 12059 SEK 2010 | Standard Deviation 18966 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 26; n=18/54 | 13615 SEK 2010 | Standard Deviation 19637 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 27; n=16/53 | 12683 SEK 2010 | Standard Deviation 19471 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 28; n=15/53 | 11890 SEK 2010 | Standard Deviation 19106 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 29; n=16/53 | 12683 SEK 2010 | Standard Deviation 19471 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 30; n=16/53 | 12683 SEK 2010 | Standard Deviation 19471 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 31; n=15/50 | 12604 SEK 2010 | Standard Deviation 19448 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 32; n=14/50 | 11763 SEK 2010 | Standard Deviation 19055 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 33; n=14/50 | 11763 SEK 2010 | Standard Deviation 19055 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 34; n=14/49 | 12003 SEK 2010 | Standard Deviation 19176 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 35; n=14/49 | 12003 SEK 2010 | Standard Deviation 19176 |
| Duodopa Naïve | Indirect Monthly Costs Per Participant (Only Applied to Participants Younger Than 65) by Study Month, SEK 2010 | Month 36; n=15/49 | 12432 SEK 2010 | Standard Deviation 19137 |
Primary
Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010
Direct medical costs consist of inpatient care, outpatient care (visits to physician, nurse, physiotherapist, occupational therapist, dietitian, speech therapist, counselor, and phone consultations). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.
Time frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duodopa Naïve | Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010 | 3825 SEK 2010 | Standard Deviation 9394 |
| Duodopa Non-naïve < 2 Years | Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010 | 4552 SEK 2010 | Standard Deviation 11819 |
| Duodopa Non-naïve ≥ 2 Years | Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010 | 3607 SEK 2010 | Standard Deviation 8648 |
| Total | Monthly Direct Medical Cost (Excluding Drug Costs) Per Participant, SEK 2010 | 4002 SEK 2010 | Standard Deviation 10069 |
Primary
Monthly Drug Costs Per Participant, SEK 2010
Drug costs include Duodopa cost and cost of concomitant anti-PD medication. Drug costs are a direct medical cost. The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.
Time frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duodopa Naïve | Monthly Drug Costs Per Participant, SEK 2010 | 39382 SEK 2010 | Standard Deviation 16733 |
| Duodopa Non-naïve < 2 Years | Monthly Drug Costs Per Participant, SEK 2010 | 34417 SEK 2010 | Standard Deviation 10494 |
| Duodopa Non-naïve ≥ 2 Years | Monthly Drug Costs Per Participant, SEK 2010 | 37679 SEK 2010 | Standard Deviation 15196 |
| Total | Monthly Drug Costs Per Participant, SEK 2010 | 37339 SEK 2010 | Standard Deviation 14725 |
Primary
Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010
Total monthly costs include * Direct medical costs (inpatient care, outpatient care, and drug costs \[including Duodopa cost and cost of concomitant anti-PD medication\]). * Direct non-medical costs (nursing home, home help, personal assistance, informal care \[from family member or friend\] and transportation to inpatient, outpatient visits and nursing home). * Indirect costs (sick-leave and early retirement due to PD \[applied to individuals only up to the age of 65 since the main indirect cost item, early retirement due to disability, is only available for individuals 30-64 years old. Sixty-five is also a common retirement age in Sweden\]). The average rate for US Dollar (USD) to SEK on 31 December 2010 was 1 USD = 6.734 SEK.
Time frame: Baseline (month -3) for Duodopa-naïve participants, then at Month 0, and monthly thereafter until study completion (up to 48 months) for all participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duodopa Naïve | Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010 | 78418 SEK 2010 | Standard Deviation 42028 |
| Duodopa Non-naïve < 2 Years | Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010 | 75521 SEK 2010 | Standard Deviation 73296 |
| Duodopa Non-naïve ≥ 2 Years | Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010 | 82177 SEK 2010 | Standard Deviation 53728 |
| Total | Total Monthly Cost Per Participant, in Swedish Crowns (SEK) 2010 | 78464 SEK 2010 | Standard Deviation 56772 |
Primary
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect); for Part IV, questions are measured on a 5- or 2-point scale (0 or 1). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.
Time frame: Baseline (Month -3), Month 12
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Total Score, Baseline (Month -3); n=27, 0, 0 | 52.1 units on a scale | Standard Deviation 16.1 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Total Score, Month 12; n=25, 20, 17 | 42.5 units on a scale | Standard Deviation 22.6 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part I, Baseline (Month -3); n=27, 0, 0 | 2.9 units on a scale | Standard Deviation 1.9 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part I, Month 12; n=25, 20, 17 | 3.1 units on a scale | Standard Deviation 2.2 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part II, Baseline (Month -3); n=27, 0, 0 | 15.4 units on a scale | Standard Deviation 5.7 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part II, Month 12; n=25, 20, 17 | 12.2 units on a scale | Standard Deviation 6.8 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part III, Baseline (Month -3); n=27, 0, 0 | 24.4 units on a scale | Standard Deviation 11 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part III, Month 12; n=25, 20, 17 | 21.5 units on a scale | Standard Deviation 13.2 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part IV, Baseline (Month -3); n=27, 0, 0 | 9.4 units on a scale | Standard Deviation 2.6 |
| Duodopa Naïve | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part IV, Month 12; n=25, 20, 17 | 5.7 units on a scale | Standard Deviation 3.4 |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part IV, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Total Score, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part II, Month 12; n=25, 20, 17 | 13.4 units on a scale | Standard Deviation 5.7 |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part II, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Total Score, Month 12; n=25, 20, 17 | 44.0 units on a scale | Standard Deviation 13.9 |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part IV, Month 12; n=25, 20, 17 | 7.0 units on a scale | Standard Deviation 2.5 |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part III, Month 12; n=25, 20, 17 | 21.2 units on a scale | Standard Deviation 10 |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part I, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part III, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part I, Month 12; n=25, 20, 17 | 2.6 units on a scale | Standard Deviation 2 |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part III, Month 12; n=25, 20, 17 | 23.5 units on a scale | Standard Deviation 11.5 |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part I, Month 12; n=25, 20, 17 | 3.2 units on a scale | Standard Deviation 2.2 |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part II, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part II, Month 12; n=25, 20, 17 | 14.3 units on a scale | Standard Deviation 6 |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part IV, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part III, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Total Score, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part IV, Month 12; n=25, 20, 17 | 7.2 units on a scale | Standard Deviation 3.5 |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Total Score, Month 12; n=25, 20, 17 | 48.2 units on a scale | Standard Deviation 18.4 |
| Duodopa Non-naïve ≥ 2 Years | Unified Parkinson's Disease Rating Scale (UPDRS) Total Score, and UPDRS Subscores I, II, III, and IV at Baseline and Month 12 | Part I, Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
Comparison: Total Score, Change From Baseline for the Duodopa Naïve group at Month 12 (n=25)p-value: 0.017Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Cramps' scores were 1 (worst) to 5 (best).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 4.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 4.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.8 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 4.7 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 4.6 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.7 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 4.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 4.7 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 4.8 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.5 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 4.7 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.8 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 4.6 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.9 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 4.7 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.7 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 4.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 4.8 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 4.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.9 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.8 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.7 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 4.7 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 4.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 4.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 4.7 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 4.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 4.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 4.8 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 4.8 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.8 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.7 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 4.8 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 4.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 4.0 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.3 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 4.0 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 4.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.1 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.9 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 4.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 4.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 4.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 4.2 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.6 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 4.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 4.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Cramps) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 4.2 units on a scale | Standard Deviation 1 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.017Wilcoxon tests
p-value: 0.191Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Drawing impairment was assessed as a spiral score, where the participant is asked to draw a spiral. 1 is worst score, 10 is best.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 5.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 4.5 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 4.2 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 4.3 units on a scale | Standard Deviation 1.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.3 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 4.8 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 4.6 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 4.1 units on a scale | Standard Deviation 1.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.4 units on a scale | Standard Deviation 1.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 4.6 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 4.4 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 3.6 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 4.5 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.5 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.8 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.1 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 4.0 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.8 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 4.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.1 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.1 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.4 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.5 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 4.3 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.3 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 4.2 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 4.5 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.6 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.1 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 4.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 4.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 4.4 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 4.3 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 3.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.9 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.4 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.8 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 4.6 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 5.0 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 4.9 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 5.2 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.5 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 5.1 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 4.5 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 4.8 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.9 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.7 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 5.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.8 units on a scale | Standard Deviation 1.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 5.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 5.3 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 5.3 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 4.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 5.0 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 5.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 5.4 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.5 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 4.9 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.6 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Drawing Impairment [Wavelet Method]) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 5.3 units on a scale | Standard Deviation 1.3 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.208Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.048Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement. Magnitude scores were 1 (worst) to 5 (best).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 4.0 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.1 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 4.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 4.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Endpoint; 23, 20, 16 | 4.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.9 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.9 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 4.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.5 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 4.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 4.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.9 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 4.0 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.2 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 4.0 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 4.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 3.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 4.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.0 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 4.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.9 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 4.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.9 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.9 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 4.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Endpoint; 23, 20, 16 | 3.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.9 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 4.2 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 4.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Endpoint; 23, 20, 16 | 3.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 4.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 4.0 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.9 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Magnitude) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 4.0 units on a scale | Standard Deviation 0.7 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 1Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.002Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Dyskinetic time' is time with involuntary muscle movement, and is represented as a percentage of total time of the last \_\_ hours.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 16.2 percentage of 'dyskinetic' time | Standard Deviation 9.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 15.8 percentage of 'dyskinetic' time | Standard Deviation 12.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 15.6 percentage of 'dyskinetic' time | Standard Deviation 13.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 17.4 percentage of 'dyskinetic' time | Standard Deviation 14.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 9.6 percentage of 'dyskinetic' time | Standard Deviation 12 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 20.8 percentage of 'dyskinetic' time | Standard Deviation 15.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 16.2 percentage of 'dyskinetic' time | Standard Deviation 9.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 20.6 percentage of 'dyskinetic' time | Standard Deviation 11.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 13.6 percentage of 'dyskinetic' time | Standard Deviation 13.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 10.4 percentage of 'dyskinetic' time | Standard Deviation 9.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 17.0 percentage of 'dyskinetic' time | Standard Deviation 14.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 16.2 percentage of 'dyskinetic' time | Standard Deviation 13.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 12.0 percentage of 'dyskinetic' time | Standard Deviation 12 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 16.5 percentage of 'dyskinetic' time | Standard Deviation 21.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 14.5 percentage of 'dyskinetic' time | Standard Deviation 16.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 14.4 percentage of 'dyskinetic' time | Standard Deviation 13 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 18.2 percentage of 'dyskinetic' time | Standard Deviation 24.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 18.6 percentage of 'dyskinetic' time | Standard Deviation 12.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 16.7 percentage of 'dyskinetic' time | Standard Deviation 17.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 24.3 percentage of 'dyskinetic' time | Standard Deviation 14.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 11.8 percentage of 'dyskinetic' time | Standard Deviation 20.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 15.9 percentage of 'dyskinetic' time | Standard Deviation 15.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 21.3 percentage of 'dyskinetic' time | Standard Deviation 15.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'dyskinetic' time | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'dyskinetic' time | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 19.6 percentage of 'dyskinetic' time | Standard Deviation 17.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 18.4 percentage of 'dyskinetic' time | Standard Deviation 12.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 13.7 percentage of 'dyskinetic' time | Standard Deviation 13.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 18.9 percentage of 'dyskinetic' time | Standard Deviation 16.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 14.4 percentage of 'dyskinetic' time | Standard Deviation 12.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 20.8 percentage of 'dyskinetic' time | Standard Deviation 16.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 15.5 percentage of 'dyskinetic' time | Standard Deviation 9.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 19.0 percentage of 'dyskinetic' time | Standard Deviation 12 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 14.6 percentage of 'dyskinetic' time | Standard Deviation 10.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 17.4 percentage of 'dyskinetic' time | Standard Deviation 13.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 15.9 percentage of 'dyskinetic' time | Standard Deviation 11.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 20.8 percentage of 'dyskinetic' time | Standard Deviation 11 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 15.0 percentage of 'dyskinetic' time | Standard Deviation 11.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 21.3 percentage of 'dyskinetic' time | Standard Deviation 19 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 19.1 percentage of 'dyskinetic' time | Standard Deviation 12.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 15.2 percentage of 'dyskinetic' time | Standard Deviation 10.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 19.4 percentage of 'dyskinetic' time | Standard Deviation 10.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 16.9 percentage of 'dyskinetic' time | Standard Deviation 11.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 19.4 percentage of 'dyskinetic' time | Standard Deviation 10.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 28.2 percentage of 'dyskinetic' time | Standard Deviation 19.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 25.8 percentage of 'dyskinetic' time | Standard Deviation 22.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'dyskinetic' time | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 32.4 percentage of 'dyskinetic' time | Standard Deviation 17.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 25.6 percentage of 'dyskinetic' time | Standard Deviation 24.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 24.8 percentage of 'dyskinetic' time | Standard Deviation 21.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 13.4 percentage of 'dyskinetic' time | Standard Deviation 14.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 24.5 percentage of 'dyskinetic' time | Standard Deviation 20 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 21.3 percentage of 'dyskinetic' time | Standard Deviation 21.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 18.2 percentage of 'dyskinetic' time | Standard Deviation 16.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 27.3 percentage of 'dyskinetic' time | Standard Deviation 19.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 23.0 percentage of 'dyskinetic' time | Standard Deviation 15.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 16.6 percentage of 'dyskinetic' time | Standard Deviation 18 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 25.1 percentage of 'dyskinetic' time | Standard Deviation 21.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 27.2 percentage of 'dyskinetic' time | Standard Deviation 24.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 19.7 percentage of 'dyskinetic' time | Standard Deviation 17.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 24.0 percentage of 'dyskinetic' time | Standard Deviation 22.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 26.5 percentage of 'dyskinetic' time | Standard Deviation 22.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'dyskinetic' time | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 27.4 percentage of 'dyskinetic' time | Standard Deviation 21.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 28.5 percentage of 'dyskinetic' time | Standard Deviation 28 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Dyskinetic Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 21.3 percentage of 'dyskinetic' time | Standard Deviation 21.1 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.048Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.003Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Free tapping' is defined as \_\_\_\_. 'Free tapping accuracy' is the percentage of accurate free taps per 20 seconds(?).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 50.3 percentage of tapping accuracy | Standard Deviation 13 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 64.4 percentage of tapping accuracy | Standard Deviation 14.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 67.0 percentage of tapping accuracy | Standard Deviation 13.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 70.1 percentage of tapping accuracy | Standard Deviation 14.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 62.3 percentage of tapping accuracy | Standard Deviation 16.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 65.4 percentage of tapping accuracy | Standard Deviation 9.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 60.1 percentage of tapping accuracy | Standard Deviation 15.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 61.2 percentage of tapping accuracy | Standard Deviation 11 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 68.7 percentage of tapping accuracy | Standard Deviation 15.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 60.7 percentage of tapping accuracy | Standard Deviation 24.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 58.9 percentage of tapping accuracy | Standard Deviation 10.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 64.7 percentage of tapping accuracy | Standard Deviation 16.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 73.4 percentage of tapping accuracy | Standard Deviation 13 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 63.7 percentage of tapping accuracy | Standard Deviation 17.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 66.8 percentage of tapping accuracy | Standard Deviation 12.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 70.0 percentage of tapping accuracy | Standard Deviation 14.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 71.4 percentage of tapping accuracy | Standard Deviation 16.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 70.7 percentage of tapping accuracy | Standard Deviation 16.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 67.6 percentage of tapping accuracy | Standard Deviation 9.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 71.9 percentage of tapping accuracy | Standard Deviation 14.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 66.3 percentage of tapping accuracy | Standard Deviation 10.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 65.7 percentage of tapping accuracy | Standard Deviation 13 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 67.2 percentage of tapping accuracy | Standard Deviation 12.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of tapping accuracy | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of tapping accuracy | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 69.8 percentage of tapping accuracy | Standard Deviation 13.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 70.7 percentage of tapping accuracy | Standard Deviation 12.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 70.3 percentage of tapping accuracy | Standard Deviation 13.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 69.7 percentage of tapping accuracy | Standard Deviation 12.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 66.2 percentage of tapping accuracy | Standard Deviation 13.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 66.1 percentage of tapping accuracy | Standard Deviation 12.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 63.6 percentage of tapping accuracy | Standard Deviation 16.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 69.9 percentage of tapping accuracy | Standard Deviation 13.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 71.5 percentage of tapping accuracy | Standard Deviation 14.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 71.7 percentage of tapping accuracy | Standard Deviation 11.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 65.4 percentage of tapping accuracy | Standard Deviation 18.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 69.1 percentage of tapping accuracy | Standard Deviation 12.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 66.2 percentage of tapping accuracy | Standard Deviation 16.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 69.1 percentage of tapping accuracy | Standard Deviation 15.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 67.3 percentage of tapping accuracy | Standard Deviation 12.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 60.3 percentage of tapping accuracy | Standard Deviation 19.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 64.6 percentage of tapping accuracy | Standard Deviation 15.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 58.7 percentage of tapping accuracy | Standard Deviation 17 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 62.7 percentage of tapping accuracy | Standard Deviation 14.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 61.9 percentage of tapping accuracy | Standard Deviation 14.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 66.7 percentage of tapping accuracy | Standard Deviation 14.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of tapping accuracy | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 62.4 percentage of tapping accuracy | Standard Deviation 11.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 64.8 percentage of tapping accuracy | Standard Deviation 17.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 65.8 percentage of tapping accuracy | Standard Deviation 12.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 62.1 percentage of tapping accuracy | Standard Deviation 13.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 63.5 percentage of tapping accuracy | Standard Deviation 13.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 60.3 percentage of tapping accuracy | Standard Deviation 13.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 67.9 percentage of tapping accuracy | Standard Deviation 10.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 65.2 percentage of tapping accuracy | Standard Deviation 10.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 59.3 percentage of tapping accuracy | Standard Deviation 13.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 61.2 percentage of tapping accuracy | Standard Deviation 12.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 60.4 percentage of tapping accuracy | Standard Deviation 9.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 61.5 percentage of tapping accuracy | Standard Deviation 8.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 63.8 percentage of tapping accuracy | Standard Deviation 13.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 65.8 percentage of tapping accuracy | Standard Deviation 13.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 67.5 percentage of tapping accuracy | Standard Deviation 10.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of tapping accuracy | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 61.4 percentage of tapping accuracy | Standard Deviation 12.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 65.8 percentage of tapping accuracy | Standard Deviation 14.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 63.6 percentage of tapping accuracy | Standard Deviation 11.2 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.599Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.048Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Free tapping is defined as voluntary repetitive finger tapping on computer-generated fields. 'Free tapping speed' is a count of the number of taps per 20 seconds.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 45.5 taps/20 seconds | Standard Deviation 8.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 47.6 taps/20 seconds | Standard Deviation 15 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 47.2 taps/20 seconds | Standard Deviation 13.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 43.5 taps/20 seconds | Standard Deviation 11.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 47.3 taps/20 seconds | Standard Deviation 14.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 48.1 taps/20 seconds | Standard Deviation 15.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 43.6 taps/20 seconds | Standard Deviation 12.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 46.9 taps/20 seconds | Standard Deviation 12.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 49.3 taps/20 seconds | Standard Deviation 16 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 46.3 taps/20 seconds | Standard Deviation 14 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 44.0 taps/20 seconds | Standard Deviation 14.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 48.7 taps/20 seconds | Standard Deviation 17.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 46.8 taps/20 seconds | Standard Deviation 15.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 41.8 taps/20 seconds | Standard Deviation 11.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 49.5 taps/20 seconds | Standard Deviation 13 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 47.4 taps/20 seconds | Standard Deviation 13.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 44.4 taps/20 seconds | Standard Deviation 12.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 39.9 taps/20 seconds | Standard Deviation 12.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 50.7 taps/20 seconds | Standard Deviation 15.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 39.7 taps/20 seconds | Standard Deviation 11.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 49.4 taps/20 seconds | Standard Deviation 15.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 50.3 taps/20 seconds | Standard Deviation 14.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 42.2 taps/20 seconds | Standard Deviation 18.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 39.2 taps/20 seconds | Standard Deviation 14.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 40.2 taps/20 seconds | Standard Deviation 12.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 42.2 taps/20 seconds | Standard Deviation 15.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 43.2 taps/20 seconds | Standard Deviation 14.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 43.4 taps/20 seconds | Standard Deviation 17.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 43.0 taps/20 seconds | Standard Deviation 15.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 45.7 taps/20 seconds | Standard Deviation 20 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 48.0 taps/20 seconds | Standard Deviation 16.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 44.5 taps/20 seconds | Standard Deviation 16.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 46.6 taps/20 seconds | Standard Deviation 15.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 43.1 taps/20 seconds | Standard Deviation 17.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 46.3 taps/20 seconds | Standard Deviation 15.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 45.5 taps/20 seconds | Standard Deviation 17.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 48.7 taps/20 seconds | Standard Deviation 14.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 42.6 taps/20 seconds | Standard Deviation 16.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 44.7 taps/20 seconds | Standard Deviation 18.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 45.6 taps/20 seconds | Standard Deviation 19.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 41.2 taps/20 seconds | Standard Deviation 16.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 43.2 taps/20 seconds | Standard Deviation 16.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 38.7 taps/20 seconds | Standard Deviation 14.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 47.6 taps/20 seconds | Standard Deviation 12 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 41.5 taps/20 seconds | Standard Deviation 12.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 48.0 taps/20 seconds | Standard Deviation 14.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 43.2 taps/20 seconds | Standard Deviation 12.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 49.3 taps/20 seconds | Standard Deviation 22.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 46.3 taps/20 seconds | Standard Deviation 13.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 41.4 taps/20 seconds | Standard Deviation 15 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 52.6 taps/20 seconds | Standard Deviation 19.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 40.3 taps/20 seconds | Standard Deviation 13 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 43.1 taps/20 seconds | Standard Deviation 16.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 51.4 taps/20 seconds | Standard Deviation 25 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 46.6 taps/20 seconds | Standard Deviation 18.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 47.0 taps/20 seconds | Standard Deviation 18.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 40.6 taps/20 seconds | Standard Deviation 14.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 46.7 taps/20 seconds | Standard Deviation 18.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 47.0 taps/20 seconds | Standard Deviation 15.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 45.9 taps/20 seconds | Standard Deviation 18.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 46.8 taps/20 seconds | Standard Deviation 16 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Free Tapping - Speed) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 50.5 taps/20 seconds | Standard Deviation 23.6 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.012Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.035Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Off time' is when PD symptoms are not adequately controlled by the drug. Magnitude scores were 1 (worst) to 5 (best).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 3.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 3.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 3; 19, 19, 13 | 3.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 2.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 2.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 6; 16, 19, 11 | 3.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 2.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 3; 19, 19, 13 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 6; 16, 19, 11 | 3.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 3.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 3.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 6; 16, 19, 11 | 3.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 3; 19, 19, 13 | 3.3 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 2.9 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 3.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.1 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.3 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.2 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.2 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.3 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Magnitude) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.0 units on a scale | Standard Deviation 0.8 |
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.003Wilcoxon tests
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.001Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Off time is when PD symptoms are not adequately controlled by the drug, and is represented as a percentage of total time awake per day.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 24.7 percentage of 'off' time | Standard Deviation 19.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 22.0 percentage of 'off' time | Standard Deviation 15.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 23.9 percentage of 'off' time | Standard Deviation 18.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 20.8 percentage of 'off' time | Standard Deviation 14.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 29.1 percentage of 'off' time | Standard Deviation 21.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 19.5 percentage of 'off' time | Standard Deviation 13.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 24.8 percentage of 'off' time | Standard Deviation 17.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 17.9 percentage of 'off' time | Standard Deviation 8.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 25.3 percentage of 'off' time | Standard Deviation 17.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 35.1 percentage of 'off' time | Standard Deviation 25.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 21.1 percentage of 'off' time | Standard Deviation 13 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 24.0 percentage of 'off' time | Standard Deviation 17.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 26.4 percentage of 'off' time | Standard Deviation 20.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 30.7 percentage of 'off' time | Standard Deviation 22.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 21.6 percentage of 'off' time | Standard Deviation 15.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 23.0 percentage of 'off' time | Standard Deviation 12.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 23.4 percentage of 'off' time | Standard Deviation 19.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 41.2 percentage of 'off' time | Standard Deviation 19.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 25.6 percentage of 'off' time | Standard Deviation 21 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 35.4 percentage of 'off' time | Standard Deviation 11.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 23.4 percentage of 'off' time | Standard Deviation 19.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 21.9 percentage of 'off' time | Standard Deviation 13.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 29.4 percentage of 'off' time | Standard Deviation 23.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'off' time | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'off' time | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 30.6 percentage of 'off' time | Standard Deviation 21.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 21.4 percentage of 'off' time | Standard Deviation 9.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 34.3 percentage of 'off' time | Standard Deviation 20 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 22.7 percentage of 'off' time | Standard Deviation 13.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 30.1 percentage of 'off' time | Standard Deviation 21.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 21.8 percentage of 'off' time | Standard Deviation 15.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 32.3 percentage of 'off' time | Standard Deviation 20.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 21.5 percentage of 'off' time | Standard Deviation 10.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 28.0 percentage of 'off' time | Standard Deviation 23.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 19.5 percentage of 'off' time | Standard Deviation 16 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 28.9 percentage of 'off' time | Standard Deviation 21.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 21.6 percentage of 'off' time | Standard Deviation 13.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 25.4 percentage of 'off' time | Standard Deviation 16 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 21.3 percentage of 'off' time | Standard Deviation 14.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 24.0 percentage of 'off' time | Standard Deviation 13.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 29.4 percentage of 'off' time | Standard Deviation 23.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 18.8 percentage of 'off' time | Standard Deviation 11.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 28.5 percentage of 'off' time | Standard Deviation 21.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 22.3 percentage of 'off' time | Standard Deviation 14.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 30.4 percentage of 'off' time | Standard Deviation 17.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 20.9 percentage of 'off' time | Standard Deviation 10.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'off' time | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 24.9 percentage of 'off' time | Standard Deviation 12.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 18.6 percentage of 'off' time | Standard Deviation 10.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 20.2 percentage of 'off' time | Standard Deviation 10.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 28.0 percentage of 'off' time | Standard Deviation 16.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 25.7 percentage of 'off' time | Standard Deviation 18.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 25.9 percentage of 'off' time | Standard Deviation 11.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 23.0 percentage of 'off' time | Standard Deviation 11.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 25.7 percentage of 'off' time | Standard Deviation 12.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 27.1 percentage of 'off' time | Standard Deviation 13.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 31.5 percentage of 'off' time | Standard Deviation 15.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 23.5 percentage of 'off' time | Standard Deviation 9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 23.8 percentage of 'off' time | Standard Deviation 16 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 25.1 percentage of 'off' time | Standard Deviation 12.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 24.9 percentage of 'off' time | Standard Deviation 16.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 22.8 percentage of 'off' time | Standard Deviation 11.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'off' time | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 20.1 percentage of 'off' time | Standard Deviation 11.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 23.6 percentage of 'off' time | Standard Deviation 15.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Off Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 23.6 percentage of 'off' time | Standard Deviation 12.2 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.008Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.107Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. On time is when PD symptoms are well controlled by the drug, and is represented as a percentage of total time of the last \_\_ hours.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 59.1 percentage of 'on' time | Standard Deviation 14.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 62.3 percentage of 'on' time | Standard Deviation 21.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 60.5 percentage of 'on' time | Standard Deviation 25.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 61.8 percentage of 'on' time | Standard Deviation 19.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 61.3 percentage of 'on' time | Standard Deviation 25.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 59.7 percentage of 'on' time | Standard Deviation 23.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 56.0 percentage of 'on' time | Standard Deviation 21.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 61.5 percentage of 'on' time | Standard Deviation 17.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 61.1 percentage of 'on' time | Standard Deviation 23.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 54.5 percentage of 'on' time | Standard Deviation 16.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 61.9 percentage of 'on' time | Standard Deviation 21.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 59.5 percentage of 'on' time | Standard Deviation 25 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 61.6 percentage of 'on' time | Standard Deviation 23.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 52.9 percentage of 'on' time | Standard Deviation 26.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 62.4 percentage of 'on' time | Standard Deviation 27.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 62.6 percentage of 'on' time | Standard Deviation 17.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 58.4 percentage of 'on' time | Standard Deviation 28 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 40.2 percentage of 'on' time | Standard Deviation 16.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 57.7 percentage of 'on' time | Standard Deviation 28.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 40.3 percentage of 'on' time | Standard Deviation 14 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 64.8 percentage of 'on' time | Standard Deviation 28.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 62.2 percentage of 'on' time | Standard Deviation 22 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 49.3 percentage of 'on' time | Standard Deviation 27.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'on' time | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'on' time | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 49.8 percentage of 'on' time | Standard Deviation 23.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 60.2 percentage of 'on' time | Standard Deviation 14.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 52.0 percentage of 'on' time | Standard Deviation 22.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 58.3 percentage of 'on' time | Standard Deviation 20.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 55.5 percentage of 'on' time | Standard Deviation 24.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 57.3 percentage of 'on' time | Standard Deviation 21.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 52.3 percentage of 'on' time | Standard Deviation 25.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 59.5 percentage of 'on' time | Standard Deviation 18.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 57.5 percentage of 'on' time | Standard Deviation 23.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 63.0 percentage of 'on' time | Standard Deviation 21.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 55.2 percentage of 'on' time | Standard Deviation 27.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 57.6 percentage of 'on' time | Standard Deviation 20.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 59.5 percentage of 'on' time | Standard Deviation 23.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 57.4 percentage of 'on' time | Standard Deviation 23.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 56.9 percentage of 'on' time | Standard Deviation 20.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 55.3 percentage of 'on' time | Standard Deviation 23.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 61.8 percentage of 'on' time | Standard Deviation 18.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 54.6 percentage of 'on' time | Standard Deviation 21.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 56.5 percentage of 'on' time | Standard Deviation 18 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 41.3 percentage of 'on' time | Standard Deviation 22 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 53.2 percentage of 'on' time | Standard Deviation 29.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'on' time | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 42.7 percentage of 'on' time | Standard Deviation 24.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 55.8 percentage of 'on' time | Standard Deviation 31.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 55.0 percentage of 'on' time | Standard Deviation 26.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 58.6 percentage of 'on' time | Standard Deviation 26.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 49.8 percentage of 'on' time | Standard Deviation 28.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 46.2 percentage of 'on' time | Standard Deviation 25.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 58.8 percentage of 'on' time | Standard Deviation 26.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 46.5 percentage of 'on' time | Standard Deviation 28 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 49.9 percentage of 'on' time | Standard Deviation 23.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 51.9 percentage of 'on' time | Standard Deviation 26.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 51.4 percentage of 'on' time | Standard Deviation 26.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 49.0 percentage of 'on' time | Standard Deviation 32.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 55.2 percentage of 'on' time | Standard Deviation 27.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 51.1 percentage of 'on' time | Standard Deviation 33.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 50.8 percentage of 'on' time | Standard Deviation 29.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of 'on' time | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 52.5 percentage of 'on' time | Standard Deviation 31.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 47.9 percentage of 'on' time | Standard Deviation 29.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (On Time) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 55.1 percentage of 'on' time | Standard Deviation 28.2 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.002Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.01Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Satisfied with function' scores were 1 (worst) to 5 (best).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.5 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 3.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.4 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 3.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.2 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 2.5 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 2.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 3.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 3.0 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 3.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 3.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 3.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 3.4 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.3 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Satisfied With Function) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.5 units on a scale | Standard Deviation 0.8 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.002Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: <0.001Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Self-assessment' scores were -3 (Off) to +3 (dyskinetic). 'Off' time is when PD symptoms are not adequately controlled by the drug. 'Dyskinetic' time is time with involuntary muscle movement. 0 is defined as the normal ON state without dyskinesia (the desired motor state). Everything closer to 0 means improvement, everything more away from 0 means either less mobility (in the negative score) or involuntary movements (dyskinesia, in the positive score).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | -0.6 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | -0.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | -0.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | -0.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | -0.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 0.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | -0.3 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | -0.2 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | -0.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | -0.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | -0.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | -0.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | -0.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | -0.3 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | -0.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | -0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | -0.2 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | -0.9 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | -0.4 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | -0.4 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | -0.4 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | -0.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | -0.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | -0.1 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | -0.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | -0.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | -0.1 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | -0.2 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 0.0 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | -0.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | -0.0 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | -0.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 0.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 0.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | -0.2 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | -0.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | -0.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | -0.3 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | -0.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 0.2 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | -0.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | -0.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 0.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 0.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | -0.0 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 0.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 0.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 0.0 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 0.2 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | -0.3 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 0.1 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 0.2 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 0.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 0.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | -0.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | -0.1 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 0.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 0.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Self-assessment) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | -0.2 units on a scale | Standard Deviation 0.8 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.047Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.847Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. 'Tapping at increased speed - accuracy' is the percentage of accurate taps per all taps on computer-generated fields.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 70.7 percentage of accurate taps | Standard Deviation 15.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 85.3 percentage of accurate taps | Standard Deviation 10.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 86.4 percentage of accurate taps | Standard Deviation 11.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 80.4 percentage of accurate taps | Standard Deviation 10.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 85.7 percentage of accurate taps | Standard Deviation 13.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 86.0 percentage of accurate taps | Standard Deviation 10.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 74.6 percentage of accurate taps | Standard Deviation 17.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 82.1 percentage of accurate taps | Standard Deviation 12.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 87.0 percentage of accurate taps | Standard Deviation 12.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 77.9 percentage of accurate taps | Standard Deviation 18.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 81.3 percentage of accurate taps | Standard Deviation 13.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 81.8 percentage of accurate taps | Standard Deviation 15.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 83.1 percentage of accurate taps | Standard Deviation 14.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 79.5 percentage of accurate taps | Standard Deviation 17.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 88.6 percentage of accurate taps | Standard Deviation 6.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 81.3 percentage of accurate taps | Standard Deviation 14.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 83.7 percentage of accurate taps | Standard Deviation 12 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 74.6 percentage of accurate taps | Standard Deviation 13.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 87.1 percentage of accurate taps | Standard Deviation 11 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 73.7 percentage of accurate taps | Standard Deviation 14.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 87.3 percentage of accurate taps | Standard Deviation 5.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 87.8 percentage of accurate taps | Standard Deviation 9.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 73.5 percentage of accurate taps | Standard Deviation 21.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 71.0 percentage of accurate taps | Standard Deviation 24.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 73.9 percentage of accurate taps | Standard Deviation 18.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 73.5 percentage of accurate taps | Standard Deviation 22.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 74.7 percentage of accurate taps | Standard Deviation 20.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 74.2 percentage of accurate taps | Standard Deviation 22.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 73.6 percentage of accurate taps | Standard Deviation 20.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 78.2 percentage of accurate taps | Standard Deviation 19 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 78.8 percentage of accurate taps | Standard Deviation 15.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 80.1 percentage of accurate taps | Standard Deviation 18.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 77.5 percentage of accurate taps | Standard Deviation 20.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 77.9 percentage of accurate taps | Standard Deviation 18.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 78.7 percentage of accurate taps | Standard Deviation 19.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 79.4 percentage of accurate taps | Standard Deviation 20.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 82.0 percentage of accurate taps | Standard Deviation 15.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 74.5 percentage of accurate taps | Standard Deviation 19.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 71.7 percentage of accurate taps | Standard Deviation 24.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 72.8 percentage of accurate taps | Standard Deviation 21.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 70.4 percentage of accurate taps | Standard Deviation 23.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 72.0 percentage of accurate taps | Standard Deviation 22.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 69.0 percentage of accurate taps | Standard Deviation 18.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 73.0 percentage of accurate taps | Standard Deviation 21.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 70.0 percentage of accurate taps | Standard Deviation 16.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 73.3 percentage of accurate taps | Standard Deviation 20.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 69.3 percentage of accurate taps | Standard Deviation 20.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 79.8 percentage of accurate taps | Standard Deviation 18.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 68.8 percentage of accurate taps | Standard Deviation 22.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 67.5 percentage of accurate taps | Standard Deviation 20.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 80.6 percentage of accurate taps | Standard Deviation 20.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 73.2 percentage of accurate taps | Standard Deviation 13.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 68.0 percentage of accurate taps | Standard Deviation 19.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 81.0 percentage of accurate taps | Standard Deviation 17.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 72.4 percentage of accurate taps | Standard Deviation 23.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 74.6 percentage of accurate taps | Standard Deviation 20 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 73.2 percentage of accurate taps | Standard Deviation 15.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 71.4 percentage of accurate taps | Standard Deviation 25.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 75.6 percentage of accurate taps | Standard Deviation 19 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 72.1 percentage of accurate taps | Standard Deviation 24.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 77.1 percentage of accurate taps | Standard Deviation 16.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Increased Speed - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 77.9 percentage of accurate taps | Standard Deviation 21.1 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.026Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.208Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds. 'Tapping random chase - accuracy' is the percentage of accurate random chase taps.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 82.1 percentage of accurate taps | Standard Deviation 16.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 92.9 percentage of accurate taps | Standard Deviation 6.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 91.2 percentage of accurate taps | Standard Deviation 8.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 92.9 percentage of accurate taps | Standard Deviation 6.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 91.7 percentage of accurate taps | Standard Deviation 10.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 92.4 percentage of accurate taps | Standard Deviation 7.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 87.3 percentage of accurate taps | Standard Deviation 12.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 91.6 percentage of accurate taps | Standard Deviation 5.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 92.2 percentage of accurate taps | Standard Deviation 8.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 83.5 percentage of accurate taps | Standard Deviation 19.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 90.2 percentage of accurate taps | Standard Deviation 11.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 91.2 percentage of accurate taps | Standard Deviation 7.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 90.5 percentage of accurate taps | Standard Deviation 17.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 87.8 percentage of accurate taps | Standard Deviation 18.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 93.6 percentage of accurate taps | Standard Deviation 4.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 92.5 percentage of accurate taps | Standard Deviation 9.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 94.6 percentage of accurate taps | Standard Deviation 4.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 92.0 percentage of accurate taps | Standard Deviation 14.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 95.2 percentage of accurate taps | Standard Deviation 4.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 91.8 percentage of accurate taps | Standard Deviation 7.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 95.1 percentage of accurate taps | Standard Deviation 3.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 94.6 percentage of accurate taps | Standard Deviation 3.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 85.9 percentage of accurate taps | Standard Deviation 11.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 90.0 percentage of accurate taps | Standard Deviation 12.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 91.3 percentage of accurate taps | Standard Deviation 10.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 89.2 percentage of accurate taps | Standard Deviation 11.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 88.6 percentage of accurate taps | Standard Deviation 13.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 89.0 percentage of accurate taps | Standard Deviation 14.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 88.7 percentage of accurate taps | Standard Deviation 14 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 90.8 percentage of accurate taps | Standard Deviation 10.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 93.1 percentage of accurate taps | Standard Deviation 7.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 90.7 percentage of accurate taps | Standard Deviation 11.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 92.5 percentage of accurate taps | Standard Deviation 8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 88.8 percentage of accurate taps | Standard Deviation 14.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 92.1 percentage of accurate taps | Standard Deviation 9.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 92.2 percentage of accurate taps | Standard Deviation 9.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 93.4 percentage of accurate taps | Standard Deviation 5.2 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 88.6 percentage of accurate taps | Standard Deviation 8.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 85.9 percentage of accurate taps | Standard Deviation 14.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 88.4 percentage of accurate taps | Standard Deviation 11.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 83.8 percentage of accurate taps | Standard Deviation 15.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 86.6 percentage of accurate taps | Standard Deviation 14.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 89.0 percentage of accurate taps | Standard Deviation 7.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 89.2 percentage of accurate taps | Standard Deviation 11.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 90.7 percentage of accurate taps | Standard Deviation 6.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 90.5 percentage of accurate taps | Standard Deviation 7.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 89.8 percentage of accurate taps | Standard Deviation 8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 90.5 percentage of accurate taps | Standard Deviation 9.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 89.1 percentage of accurate taps | Standard Deviation 10.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 86.7 percentage of accurate taps | Standard Deviation 9.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 91.2 percentage of accurate taps | Standard Deviation 7.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 92.3 percentage of accurate taps | Standard Deviation 7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 87.5 percentage of accurate taps | Standard Deviation 8.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 89.7 percentage of accurate taps | Standard Deviation 7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 89.2 percentage of accurate taps | Standard Deviation 7.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 90.6 percentage of accurate taps | Standard Deviation 5.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 92.6 percentage of accurate taps | Standard Deviation 6.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 86.8 percentage of accurate taps | Standard Deviation 13.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 92.5 percentage of accurate taps | Standard Deviation 4.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA percentage of accurate taps | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 85.4 percentage of accurate taps | Standard Deviation 15.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 91.8 percentage of accurate taps | Standard Deviation 6.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Accuracy) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 88.8 percentage of accurate taps | Standard Deviation 7.5 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.048Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.03Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Tapping: Random chase speed' is defined as the number of correct taps of fields randomly selected by the computer per 20 seconds.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 25.2 taps/20 seconds | Standard Deviation 2.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 26.7 taps/20 seconds | Standard Deviation 5.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 27.2 taps/20 seconds | Standard Deviation 4.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 26.3 taps/20 seconds | Standard Deviation 5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 27.0 taps/20 seconds | Standard Deviation 5.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 27.0 taps/20 seconds | Standard Deviation 4.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Endpoint; 23, 20, 16 | 25.1 taps/20 seconds | Standard Deviation 4.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 26.3 taps/20 seconds | Standard Deviation 3.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 27.2 taps/20 seconds | Standard Deviation 5.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 26.5 taps/20 seconds | Standard Deviation 5.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 26.2 taps/20 seconds | Standard Deviation 4.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 26.3 taps/20 seconds | Standard Deviation 5.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 27.2 taps/20 seconds | Standard Deviation 5.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 25.1 taps/20 seconds | Standard Deviation 5.5 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 27.9 taps/20 seconds | Standard Deviation 4.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 27.2 taps/20 seconds | Standard Deviation 4.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 26.3 taps/20 seconds | Standard Deviation 4.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 24.5 taps/20 seconds | Standard Deviation 4.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 28.3 taps/20 seconds | Standard Deviation 4.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 24.2 taps/20 seconds | Standard Deviation 4.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 27.4 taps/20 seconds | Standard Deviation 4.6 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 28.2 taps/20 seconds | Standard Deviation 4.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 24.4 taps/20 seconds | Standard Deviation 6.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 22.6 taps/20 seconds | Standard Deviation 5.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 23.4 taps/20 seconds | Standard Deviation 5.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 23.8 taps/20 seconds | Standard Deviation 5.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 24.4 taps/20 seconds | Standard Deviation 6.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 24.2 taps/20 seconds | Standard Deviation 5.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 24.4 taps/20 seconds | Standard Deviation 5.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 24.4 taps/20 seconds | Standard Deviation 5.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 25.6 taps/20 seconds | Standard Deviation 4.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 25.5 taps/20 seconds | Standard Deviation 5.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 26.4 taps/20 seconds | Standard Deviation 4.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 24.9 taps/20 seconds | Standard Deviation 6.4 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 25.9 taps/20 seconds | Standard Deviation 6.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 24.8 taps/20 seconds | Standard Deviation 5.6 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 26.5 taps/20 seconds | Standard Deviation 5.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 25.1 taps/20 seconds | Standard Deviation 5.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 23.1 taps/20 seconds | Standard Deviation 6.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 23.9 taps/20 seconds | Standard Deviation 6.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 22.7 taps/20 seconds | Standard Deviation 6.3 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Endpoint; 23, 20, 16 | 23.6 taps/20 seconds | Standard Deviation 6.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 24; n=13, 13, 7 | 22.7 taps/20 seconds | Standard Deviation 5.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 25.3 taps/20 seconds | Standard Deviation 4.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 23.8 taps/20 seconds | Standard Deviation 4.6 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 24.4 taps/20 seconds | Standard Deviation 4.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 24.0 taps/20 seconds | Standard Deviation 3.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 25.1 taps/20 seconds | Standard Deviation 7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 3; n=19, 18, 13 | 24.3 taps/20 seconds | Standard Deviation 3.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Endpoint; 23, 20, 16 | 23.0 taps/20 seconds | Standard Deviation 6.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 27.0 taps/20 seconds | Standard Deviation 5.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 22.0 taps/20 seconds | Standard Deviation 4.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 22.8 taps/20 seconds | Standard Deviation 5.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 25.1 taps/20 seconds | Standard Deviation 6.8 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 24.7 taps/20 seconds | Standard Deviation 5.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 23.8 taps/20 seconds | Standard Deviation 5.4 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 22.7 taps/20 seconds | Standard Deviation 4.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 24.8 taps/20 seconds | Standard Deviation 6.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 25.6 taps/20 seconds | Standard Deviation 4.7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA taps/20 seconds | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 25.0 taps/20 seconds | Standard Deviation 7 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 25.0 taps/20 seconds | Standard Deviation 5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Tapping, Random Chase - Speed) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 26.3 taps/20 seconds | Standard Deviation 6.3 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.01Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.073Wilcoxon tests
Secondary
Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36
The Electronic Diary consisted of 15 items addressing motor performance, complication of therapy, self-assessment, and various types of tapping. Six conceptual dimensions were defined; four subjectively-reported: 'walking', 'satisfied', 'dyskinesia', and 'off' and two objectively-measured: 'tapping' and 'spiral'. Each of the items was assessed in the morning and during the day. Walking scores ranged from 1 (worst) to 5 (best).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.9 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.6 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.7 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 24; n=14, 13, 7 | 3.4 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 4.0 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.4 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.6 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 2.3 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.7 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 3; n=19, 19, 13 | 3.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 2.8 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.3 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | 2.7 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.5 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | 3.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.4 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 4.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 3; n=19, 19, 13 | 3.0 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.6 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 3.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.8 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.5 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 24; n=14, 13, 7 | 3.5 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 3.9 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 4.0 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.6 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 4.0 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 24; n=14, 13, 7 | 2.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 6; n=16, 19, 11 | 3.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 24; n=13, 13, 7 | 2.8 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 6; n=16, 19, 11 | 3.3 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 3; n=19, 19, 13 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 30; n=9, 9, 5 | 3.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 3; n=19, 19, 13 | 3.1 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Endpoint; n=23, 20, 16 | 3.0 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 30; n=9, 9, 5 | 3.9 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 0; n=19, 20, 15 | 3.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Endpoint; n=23, 20, 16 | 3.0 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 36; n=6, 11, 5 | 3.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 12; n=16, 16, 9 | 3.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 12; n=16, 16, 9 | 3.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 0; n=19, 20, 15 | 3.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 18; n=15, 14, 10 | 3.4 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 9; n=16, 17, 9 | 3.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Baseline (Month -3); n=20, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 18; n=15, 14, 10 | 3.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Morning, Month 9; n=16, 17, 9 | 3.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | Electronic Diary: Morning and Day Scores (Walking) From Baseline to Month 36 | Day, Month 36; n=5, 11, 5 | 3.7 units on a scale | Standard Deviation 0.6 |
Comparison: Change from Baseline to Month 12 for morning scoresp-value: 0.016Wilcoxon tests
Comparison: Change from Baseline to Month 12 for day scoresp-value: 0.188Wilcoxon tests
Secondary
MADRS Apparent Sadness Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Apparent sadness scores rate despondency, gloom and despair (more than just ordinary transient low spirits), reflected in speech, facial expression, and posture.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.4 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 0.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.2 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.0 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Apparent Sadness Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.8 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.3 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Apparent Sadness Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.5 units on a scale | Standard Deviation 0.6 |
Secondary
MADRS Concentration Difficulties Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Concentration Difficulties scores rate difficulties in collecting one's thoughts mounting to an incapacitating lack of concentration.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.5 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.6 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.5 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 1.0 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.9 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.5 units on a scale | Standard Deviation 1.7 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.2 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.6 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.5 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 1.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.1 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.7 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.1 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.7 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.2 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 1.2 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.5 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.9 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.4 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.6 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.4 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Concentration Difficulties Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.2 units on a scale | Standard Deviation 1.1 |
Secondary
MADRS Inability to Feel Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inability to Feel scores rate the subjective experience of reduced interest in the surroundings, or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 0.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.6 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Inability to Feel Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.2 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.1 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.6 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.7 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.9 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.8 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inability to Feel Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.8 units on a scale | Standard Deviation 1.3 |
Secondary
MADRS Inner Tension Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Inner Tension scores rate feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread or anguish.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.0 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.7 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.1 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 1.3 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 1.5 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.3 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.1 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.1 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Inner Tension Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.6 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.0 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.8 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.8 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.3 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.5 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.5 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.8 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Inner Tension Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.2 units on a scale | Standard Deviation 1.1 |
Secondary
MADRS Lassitude Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Lassitude scores rate difficulty in getting started or slowness in initiating and performing everyday activities.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.7 units on a scale | Standard Deviation 1.5 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.9 units on a scale | Standard Deviation 1.5 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.8 units on a scale | Standard Deviation 1.6 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.6 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 1.3 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 1.7 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.4 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.0 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.5 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Lassitude Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.8 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.6 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.4 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 1.5 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.5 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.5 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.4 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.9 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.7 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.8 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve < 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 2.0 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.3 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.7 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.4 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.7 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.6 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Lassitude Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.3 units on a scale | Standard Deviation 1.5 |
Secondary
MADRS Pessimistic Thoughts Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Pessimistic Thoughts scores rate thoughts of guilt, inferiority, self-reproach, sinfulness, remorse and ruin.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 0.9 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.0 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.9 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.0 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.0 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 30; n=22, 17, 13 | 1.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.0 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 1.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.5 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.5 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 30; n=22, 17, 13 | 0.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 1.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.0 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 30; n=22, 17, 13 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Pessimistic Thoughts Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.8 units on a scale | Standard Deviation 1 |
Secondary
MADRS Reduced Appetite Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Appetite scores rate the feeling of a loss of appetite compared with when-well. Rate by loss of desire for food or the need to force oneself to eat.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.7 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.9 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 0.8 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.7 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.0 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.8 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Reduced Appetite Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.9 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.2 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.3 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.1 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.7 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.7 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.8 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Appetite Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.5 units on a scale | Standard Deviation 1.2 |
Secondary
MADRS Reduced Sleep Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reduced Sleep scores rate the experience of reduced duration or depth of sleep compared to the participant's own normal pattern when well.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.6 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.8 units on a scale | Standard Deviation 1.5 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.9 units on a scale | Standard Deviation 1.7 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.7 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.8 units on a scale | Standard Deviation 1.5 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 2.5 units on a scale | Standard Deviation 1.7 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 2.0 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.9 units on a scale | Standard Deviation 1.6 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.3 units on a scale | Standard Deviation 1.7 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.8 units on a scale | Standard Deviation 1.8 |
| Duodopa Naïve | MADRS Reduced Sleep Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.6 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.5 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.5 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 1.8 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.7 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.5 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.8 units on a scale | Standard Deviation 1.9 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.9 units on a scale | Standard Deviation 1.9 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.2 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve < 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.4 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.2 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.5 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 1.2 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 1.7 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.2 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.4 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 2.0 units on a scale | Standard Deviation 2.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.7 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reduced Sleep Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.5 units on a scale | Standard Deviation 1.7 |
Secondary
MADRS Reported Sadness Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Reported Sadness scores rate depressed mood, regardless of whether it is reflected in appearance or not, and includes low spirits, despondency or the feeling of being beyond help and without hope.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 1.0 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 1.0 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 1.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 1.1 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Reported Sadness Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.2 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 1.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.8 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.9 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.9 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.8 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 1.1 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.9 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.8 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.8 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 1.1 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 1.0 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Reported Sadness Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.5 units on a scale | Standard Deviation 0.7 |
Secondary
MADRS Suicidal Thoughts Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Suicidal Thoughts scores rate the feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 0.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.5 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.5 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.1 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.5 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.1 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.2 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.1 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.3 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.2 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.2 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.1 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve < 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.0 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 0.2 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 0.2 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 0.2 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 0.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 0.4 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 0.2 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 0.1 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 0.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 0.2 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | MADRS Suicidal Thoughts Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 0.4 units on a scale | Standard Deviation 0.8 |
Secondary
Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36
The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint visit (Month 36 or last visit if discontinued early)
Population: Full Analysis Set: Participants who had ≥ 1 dose of study medication and (for Duodopa naives) had data for baseline and ≥ 1 post-baseline assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥ 1 more assessment of the primary efficacy measurements UPDRS and EQ-5D.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 27.7 units on a scale | Standard Deviation 2.5 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 28.4 units on a scale | Standard Deviation 2.3 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 27.2 units on a scale | Standard Deviation 3.2 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 27.6 units on a scale | Standard Deviation 2.7 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 27.9 units on a scale | Standard Deviation 2.8 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 28.2 units on a scale | Standard Deviation 2.2 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 28.0 units on a scale | Standard Deviation 2.9 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 27.8 units on a scale | Standard Deviation 2.4 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 27.3 units on a scale | Standard Deviation 3.9 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 28.1 units on a scale | Standard Deviation 2.5 |
| Duodopa Naïve | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 27.1 units on a scale | Standard Deviation 3.9 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 28.2 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 28.0 units on a scale | Standard Deviation 2.2 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 27.2 units on a scale | Standard Deviation 2.8 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 27.6 units on a scale | Standard Deviation 1.9 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 27.6 units on a scale | Standard Deviation 2 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 28.5 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 27.8 units on a scale | Standard Deviation 2 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 26.4 units on a scale | Standard Deviation 3.4 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 26.3 units on a scale | Standard Deviation 4 |
| Duodopa Non-naïve < 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 26.4 units on a scale | Standard Deviation 3.8 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 27.9 units on a scale | Standard Deviation 4.1 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 28.0 units on a scale | Standard Deviation 2.2 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 28.6 units on a scale | Standard Deviation 1.9 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 28.6 units on a scale | Standard Deviation 2 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 28.2 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 28.2 units on a scale | Standard Deviation 2.5 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 28.3 units on a scale | Standard Deviation 2.1 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 27.3 units on a scale | Standard Deviation 3.8 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 28.3 units on a scale | Standard Deviation 2.3 |
| Duodopa Non-naïve ≥ 2 Years | Mini Mental Status Examination (MMSE) Total Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 28.1 units on a scale | Standard Deviation 1.4 |
Secondary
MMSE Attention and Calculation Subscale Scores From Baseline to Month 36
The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Attention and Calculation subscale results in a total possible score of 0 to 5, with higher scores indicating better function.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 4.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 4.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 4.2 units on a scale | Standard Deviation 1.5 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 4.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 4.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 4.9 units on a scale | Standard Deviation 0.4 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 4.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 4.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 4.6 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 4.6 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 4.2 units on a scale | Standard Deviation 1.5 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 4.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 4.4 units on a scale | Standard Deviation 1.4 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 4.3 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 4.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 4.3 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 4.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 4.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 4.1 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 3.7 units on a scale | Standard Deviation 1.9 |
| Duodopa Non-naïve < 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 4.0 units on a scale | Standard Deviation 1.7 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 4.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 4.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 4.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 4.8 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 4.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 4.6 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 4.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 4.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 4.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Attention and Calculation Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 4.7 units on a scale | Standard Deviation 0.6 |
Secondary
MMSE Language Subscale Scores From Baseline to Month 36
The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Language subscale results in a total possible score of 0 to 9, with higher scores indicating better function.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 8.0 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 8.4 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 8.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 8.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 8.2 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 8.3 units on a scale | Standard Deviation 1.6 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 8.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 8.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 7.9 units on a scale | Standard Deviation 1.4 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 8.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Language Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 8.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 8.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 8.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 8.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 8.1 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 8.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 8.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 8.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 8.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 7.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve < 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 7.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 8.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 8.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 8.7 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 8.5 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 8.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 8.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 8.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 8.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 8.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Language Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 8.3 units on a scale | Standard Deviation 0.7 |
Secondary
MMSE Orientation Subscale Scores From Baseline to Month 36
The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The orientation subscale has a total possible score of 0 to 10, with higher scores indicating better function.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 9.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 9.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 9.6 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 9.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 9.6 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 9.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 9.4 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 9.6 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 9.4 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 9.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MMSE Orientation Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 9.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 9.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 9.9 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 9.5 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 9.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 9.9 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 9.7 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 9.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 8.9 units on a scale | Standard Deviation 1.9 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 9.3 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 8.9 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 9.1 units on a scale | Standard Deviation 2.2 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 9.9 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 9.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 9.8 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 9.8 units on a scale | Standard Deviation 0.4 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 9.7 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 9.6 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 9.2 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 9.9 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Orientation Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 9.7 units on a scale | Standard Deviation 0.6 |
Secondary
MMSE Recall Subscale Scores From Baseline to Month 36
The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Recall subscale results in a total possible score of 0 to 3, with higher scores indicating better function.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 2.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 2.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 2.3 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 2.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.2 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 2.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | MMSE Recall Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 2.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 2.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 2.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 2.5 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 2.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.4 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 2.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.8 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 2.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 2.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 2.5 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 2.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Recall Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 2.3 units on a scale | Standard Deviation 0.8 |
Secondary
MMSE Registration Subscale Scores From Baseline to Month 36
The MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The Registration subscale a total possible score of 0 to 3, with higher scores indicating better function.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 3.0 units on a scale | Standard Deviation 0.2 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 3.0 units on a scale | Standard Deviation 0.2 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 3.0 units on a scale | Standard Deviation 0.2 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Naïve | MMSE Registration Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 3.0 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 3.0 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.9 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve < 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.9 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 30; n=23, 17, 13 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Endpoint; n=27, 22, 17 | 2.9 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 3.0 units on a scale | Standard Deviation 0 |
| Duodopa Non-naïve ≥ 2 Years | MMSE Registration Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 3.0 units on a scale | Standard Deviation 0 |
Secondary
Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36
The best PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 2.3 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 9; 25, 20, 17 | 2.2 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.5 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 2.2 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 2.2 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.5 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 2.0 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 2.6 units on a scale | Standard Deviation 1.2 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.5 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 2.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 9; 25, 20, 17 | 2.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 2.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 2.6 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.6 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.6 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 2.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 3.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 2.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.6 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 3.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 9; 25, 20, 17 | 2.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 3.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 2.9 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Best Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 2.6 units on a scale | Standard Deviation 0.9 |
Secondary
Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36
The current stage of PD was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 24; 23, 18, 15 | 2.5 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 2.4 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.7 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 2.4 units on a scale | Standard Deviation 0.9 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 2.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.7 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 2.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 2.7 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 2.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 2.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 2.7 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 2.6 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 2.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 2.7 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 24; 23, 18, 15 | 3.0 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 2.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 2.9 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 3.1 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 3.3 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 24; 23, 18, 15 | 3.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 3.0 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 3.1 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 3.2 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 3.3 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 3.1 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 3.4 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 3.4 units on a scale | Standard Deviation 1 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Current Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 3.1 units on a scale | Standard Deviation 0.8 |
Secondary
Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36
The worst PD stage that the participant experienced during the last month was characterized according to Modified Hoehn and Yahr criteria, measured on the following 8-point scale for staging: 0=no signs of disease; 1=unilateral disease; 1.5=unilateral plus axial involvement; 2=bilateral disease; 2.5=mild bilateral disease; 3=mild to moderate bilateral disease; 4=severe disability; and 5=wheelchair bound or bedridden unless aided.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 3.9 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 3.7 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 3.9 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 3.8 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 3.6 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 3.8 units on a scale | Standard Deviation 1 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 3.8 units on a scale | Standard Deviation 1.2 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 3.6 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 4.0 units on a scale | Standard Deviation 1.1 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 3.7 units on a scale | Standard Deviation 1.3 |
| Duodopa Naïve | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 3.9 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 3.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 3.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 3.7 units on a scale | Standard Deviation 0.9 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 3.7 units on a scale | Standard Deviation 1.1 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 3.8 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 3.9 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 3.8 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 4.0 units on a scale | Standard Deviation 0.8 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 4.0 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve < 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 4.0 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 4.6 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 4.4 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 4.1 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 4.5 units on a scale | Standard Deviation 0.7 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 4.0 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 4.2 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 4.0 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 4.5 units on a scale | Standard Deviation 0.5 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 4.3 units on a scale | Standard Deviation 0.6 |
| Duodopa Non-naïve ≥ 2 Years | Modified Hoehn and Yahr Staging: Worst Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 4.0 units on a scale | Standard Deviation 0.7 |
Secondary
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36
MADRS is a depression rating scale consisting of 10 items representing the core symptoms of depressive illness, each rated 0 (no symptom) to 6 (severe symptom). Total score ranges from 0 (no depression) to 60 (severely depressed).
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 10.1 units on a scale | Standard Deviation 5.6 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 8.8 units on a scale | Standard Deviation 4.9 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 12.2 units on a scale | Standard Deviation 7.3 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 10.6 units on a scale | Standard Deviation 6.2 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 8.6 units on a scale | Standard Deviation 5.7 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | 10.3 units on a scale | Standard Deviation 5.6 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 10.2 units on a scale | Standard Deviation 6.3 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 9.0 units on a scale | Standard Deviation 5.3 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 30; n=22, 17, 13 | 12.0 units on a scale | Standard Deviation 5.9 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 10.5 units on a scale | Standard Deviation 6.9 |
| Duodopa Naïve | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 11.6 units on a scale | Standard Deviation 7 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 8.8 units on a scale | Standard Deviation 5.2 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 7.8 units on a scale | Standard Deviation 5.2 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 8.1 units on a scale | Standard Deviation 4.9 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 8.4 units on a scale | Standard Deviation 3.8 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 8.0 units on a scale | Standard Deviation 3.4 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 8.1 units on a scale | Standard Deviation 4.5 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 9.7 units on a scale | Standard Deviation 5.5 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 30; n=22, 17, 13 | 10.6 units on a scale | Standard Deviation 4.6 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 9.1 units on a scale | Standard Deviation 4.5 |
| Duodopa Non-naïve < 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 9.0 units on a scale | Standard Deviation 4.9 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 36; n=21, 16, 12 | 10.4 units on a scale | Standard Deviation 9.4 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 24; n=23, 18, 15 | 11.1 units on a scale | Standard Deviation 7.4 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 3; n=24, 22, 17 | 8.4 units on a scale | Standard Deviation 5.8 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Baseline (Month -3); n=26, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 30; n=22, 17, 13 | 9.0 units on a scale | Standard Deviation 5 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 8.8 units on a scale | Standard Deviation 5.8 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 9.5 units on a scale | Standard Deviation 7.3 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 9.9 units on a scale | Standard Deviation 6.5 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 12.3 units on a scale | Standard Deviation 9.1 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 18; n=24, 19, 16 | 9.1 units on a scale | Standard Deviation 7.1 |
| Duodopa Non-naïve ≥ 2 Years | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 8.5 units on a scale | Standard Deviation 5.3 |
Secondary
Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible, which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 33.6 units on a scale | Standard Deviation 10.8 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 0; n=27, 20, 17 | 27.1 units on a scale | Standard Deviation 11.8 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 3; n=22, 20, 18 | 24.5 units on a scale | Standard Deviation 10.1 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 6; n=24, 20, 17 | 27.9 units on a scale | Standard Deviation 10.6 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 9; n=23, 20, 16 | 25.9 units on a scale | Standard Deviation 10.6 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 12; n=23, 19, 17 | 28.8 units on a scale | Standard Deviation 12.8 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 18; n=22, 18, 16 | 28.2 units on a scale | Standard Deviation 12.2 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 24; n=21, 17, 14 | 30.3 units on a scale | Standard Deviation 12.4 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 30; n=21, 16, 12 | 33.5 units on a scale | Standard Deviation 13.1 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Endpoint; n=25, 21, 17 | 36.2 units on a scale | Standard Deviation 14.1 |
| Duodopa Naïve | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 36; n=20, 15, 11 | 36.8 units on a scale | Standard Deviation 15.1 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 6; n=24, 20, 17 | 33.4 units on a scale | Standard Deviation 16.2 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 9; n=23, 20, 16 | 30.9 units on a scale | Standard Deviation 12.1 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 36; n=20, 15, 11 | 31.5 units on a scale | Standard Deviation 11.5 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 12; n=23, 19, 17 | 33.2 units on a scale | Standard Deviation 15.5 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 18; n=22, 18, 16 | 30.4 units on a scale | Standard Deviation 15.7 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 24; n=21, 17, 14 | 36.2 units on a scale | Standard Deviation 14.6 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 0; n=27, 20, 17 | 30.3 units on a scale | Standard Deviation 10.7 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Endpoint; n=25, 21, 17 | 34.0 units on a scale | Standard Deviation 13.6 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 3; n=22, 20, 18 | 30.0 units on a scale | Standard Deviation 15.6 |
| Duodopa Non-naïve < 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 30; n=21, 16, 12 | 34.8 units on a scale | Standard Deviation 16.2 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 0; n=27, 20, 17 | 36.6 units on a scale | Standard Deviation 15.4 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 30; n=21, 16, 12 | 34.4 units on a scale | Standard Deviation 17.4 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 3; n=22, 20, 18 | 34.0 units on a scale | Standard Deviation 15.2 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 9; n=23, 20, 16 | 35.1 units on a scale | Standard Deviation 15.9 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 24; n=21, 17, 14 | 33.6 units on a scale | Standard Deviation 13.6 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 12; n=23, 19, 17 | 38.3 units on a scale | Standard Deviation 19.3 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 36; n=20, 15, 11 | 39.2 units on a scale | Standard Deviation 18 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 6; n=24, 20, 17 | 35.5 units on a scale | Standard Deviation 16.5 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Month 18; n=22, 18, 16 | 34.1 units on a scale | Standard Deviation 17 |
| Duodopa Non-naïve ≥ 2 Years | Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index Scores From Baseline to Month 36 | Endpoint; n=25, 21, 17 | 40.3 units on a scale | Standard Deviation 17.5 |
Comparison: Change from Baseline for the Duodopa Naïve group at Month 0 (n=27)p-value: 0.001Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 3 (n=23)p-value: <0.001Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 6 (n=24)p-value: 0.022Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 9 (n=23)p-value: 0.005Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 12 (n=23)p-value: 0.126Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 18 (n=22)p-value: 0.049Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 24 (n=21)p-value: 0.203Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 30 (n=21)p-value: 0.733Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Month 36 (n=20)p-value: 0.414Wilcoxon tests
Comparison: Change from Baseline for the Duodopa Naïve group at Endpoint (n=27)p-value: 0.534Wilcoxon tests
Secondary
PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 37.1 units on a scale | Standard Deviation 22.1 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 29.8 units on a scale | Standard Deviation 19.2 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 45.4 units on a scale | Standard Deviation 25.1 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 33.2 units on a scale | Standard Deviation 20.1 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 34.7 units on a scale | Standard Deviation 20.8 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 38.7 units on a scale | Standard Deviation 21.5 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 26.9 units on a scale | Standard Deviation 16.6 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 0; n=27, 20, 18 | 32.1 units on a scale | Standard Deviation 19 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 38.8 units on a scale | Standard Deviation 23.8 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 31.8 units on a scale | Standard Deviation 18.9 |
| Duodopa Naïve | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 43.4 units on a scale | Standard Deviation 23.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 42.1 units on a scale | Standard Deviation 20.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 0; n=27, 20, 18 | 40.8 units on a scale | Standard Deviation 19.1 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 42.8 units on a scale | Standard Deviation 21.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 43.7 units on a scale | Standard Deviation 23.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 37.5 units on a scale | Standard Deviation 18.4 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 41.9 units on a scale | Standard Deviation 22.9 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 48.3 units on a scale | Standard Deviation 20.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 48.5 units on a scale | Standard Deviation 19.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 47.5 units on a scale | Standard Deviation 18.4 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 48.3 units on a scale | Standard Deviation 18.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 54.5 units on a scale | Standard Deviation 29.3 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 41.9 units on a scale | Standard Deviation 24.1 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 41.7 units on a scale | Standard Deviation 22.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 46.5 units on a scale | Standard Deviation 28.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 0; n=27, 20, 18 | 46.5 units on a scale | Standard Deviation 26.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 45.6 units on a scale | Standard Deviation 26.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 42.2 units on a scale | Standard Deviation 21.3 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 53.4 units on a scale | Standard Deviation 24.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 45.8 units on a scale | Standard Deviation 24.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Activities of Daily Living Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 42.1 units on a scale | Standard Deviation 22.5 |
Secondary
PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 42.9 units on a scale | Standard Deviation 24.2 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 36.3 units on a scale | Standard Deviation 18.8 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 42.9 units on a scale | Standard Deviation 17.9 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 38.5 units on a scale | Standard Deviation 23.5 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 39.3 units on a scale | Standard Deviation 21 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 42.6 units on a scale | Standard Deviation 19.8 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 38.5 units on a scale | Standard Deviation 21.7 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 41.7 units on a scale | Standard Deviation 18.3 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 42.8 units on a scale | Standard Deviation 23.3 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 38.9 units on a scale | Standard Deviation 22.1 |
| Duodopa Naïve | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 42.6 units on a scale | Standard Deviation 19.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 34.6 units on a scale | Standard Deviation 20.1 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 40.2 units on a scale | Standard Deviation 17.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 39.8 units on a scale | Standard Deviation 20.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 42.1 units on a scale | Standard Deviation 20.5 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 42.1 units on a scale | Standard Deviation 23.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 37.1 units on a scale | Standard Deviation 20.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 35.3 units on a scale | Standard Deviation 25.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 39.2 units on a scale | Standard Deviation 24.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 31.7 units on a scale | Standard Deviation 15.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 36.7 units on a scale | Standard Deviation 20.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 37.1 units on a scale | Standard Deviation 20.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 38.9 units on a scale | Standard Deviation 23.7 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 44.0 units on a scale | Standard Deviation 21.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 34.7 units on a scale | Standard Deviation 27.3 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 43.1 units on a scale | Standard Deviation 24.8 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 46.6 units on a scale | Standard Deviation 27.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 41.2 units on a scale | Standard Deviation 24.7 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 39.7 units on a scale | Standard Deviation 24.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 42.7 units on a scale | Standard Deviation 24.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Bodily Discomfort Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 39.4 units on a scale | Standard Deviation 23.2 |
Secondary
PDQ-39 Cognition Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 24.7 units on a scale | Standard Deviation 14.7 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 21.5 units on a scale | Standard Deviation 14.9 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 36; n=20, 15, 11 | 34.1 units on a scale | Standard Deviation 19.4 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 28.6 units on a scale | Standard Deviation 20.2 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 26.8 units on a scale | Standard Deviation 20.8 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 30.6 units on a scale | Standard Deviation 15.6 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 24.2 units on a scale | Standard Deviation 17.7 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 22.5 units on a scale | Standard Deviation 13.7 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 30; n=22, 16, 12 | 31.5 units on a scale | Standard Deviation 18.6 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 25.5 units on a scale | Standard Deviation 13.7 |
| Duodopa Naïve | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Endpoint; n=25, 22, 17 | 31.5 units on a scale | Standard Deviation 19.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 33.1 units on a scale | Standard Deviation 19.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 33.0 units on a scale | Standard Deviation 16.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 36.6 units on a scale | Standard Deviation 18.5 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 37.8 units on a scale | Standard Deviation 18.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 35.6 units on a scale | Standard Deviation 20 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 31.3 units on a scale | Standard Deviation 22.1 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 41.9 units on a scale | Standard Deviation 16.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 30; n=22, 16, 12 | 45.7 units on a scale | Standard Deviation 23.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 36; n=20, 15, 11 | 42.1 units on a scale | Standard Deviation 16.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Endpoint; n=25, 22, 17 | 39.2 units on a scale | Standard Deviation 20.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 36; n=20, 15, 11 | 30.7 units on a scale | Standard Deviation 19.7 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 27.5 units on a scale | Standard Deviation 19 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 32.3 units on a scale | Standard Deviation 20.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 30; n=22, 16, 12 | 30.7 units on a scale | Standard Deviation 24.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 33.7 units on a scale | Standard Deviation 16.9 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 33.8 units on a scale | Standard Deviation 23.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 31.6 units on a scale | Standard Deviation 19.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Endpoint; n=25, 22, 17 | 34.9 units on a scale | Standard Deviation 19.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 30.1 units on a scale | Standard Deviation 23.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Cognition Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 30.6 units on a scale | Standard Deviation 16.9 |
Secondary
PDQ-39 Communication Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 28.2 units on a scale | Standard Deviation 19.6 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 25.3 units on a scale | Standard Deviation 23.3 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 33.7 units on a scale | Standard Deviation 20.7 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 31.6 units on a scale | Standard Deviation 21.8 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 29.7 units on a scale | Standard Deviation 20.1 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 32.4 units on a scale | Standard Deviation 21.6 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 24.7 units on a scale | Standard Deviation 20.3 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 24.1 units on a scale | Standard Deviation 18.7 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 33.7 units on a scale | Standard Deviation 22.6 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 24.0 units on a scale | Standard Deviation 17.1 |
| Duodopa Naïve | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 34.0 units on a scale | Standard Deviation 20.9 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 34.2 units on a scale | Standard Deviation 18.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 27.3 units on a scale | Standard Deviation 14.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 32.2 units on a scale | Standard Deviation 22.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 32.5 units on a scale | Standard Deviation 22 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 31.7 units on a scale | Standard Deviation 17.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 32.1 units on a scale | Standard Deviation 19 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 34.8 units on a scale | Standard Deviation 18.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 37.7 units on a scale | Standard Deviation 18.4 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 33.3 units on a scale | Standard Deviation 13 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 33.0 units on a scale | Standard Deviation 15.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 37.9 units on a scale | Standard Deviation 19.1 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 30.6 units on a scale | Standard Deviation 19.1 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 31.9 units on a scale | Standard Deviation 19.9 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 41.7 units on a scale | Standard Deviation 26.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 35.2 units on a scale | Standard Deviation 18.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 33.8 units on a scale | Standard Deviation 16 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 28.9 units on a scale | Standard Deviation 21.3 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 40.2 units on a scale | Standard Deviation 18.7 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 29.7 units on a scale | Standard Deviation 20.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Communication Subscale Scores From Baseline to Month 36 | Month 6; n=24, 21, 18 | 33.8 units on a scale | Standard Deviation 19.3 |
Secondary
PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 31.9 units on a scale | Standard Deviation 17.3 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 33.0 units on a scale | Standard Deviation 18 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 39.7 units on a scale | Standard Deviation 18.5 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 32.1 units on a scale | Standard Deviation 16.2 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 29.0 units on a scale | Standard Deviation 17.8 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 35.3 units on a scale | Standard Deviation 19.3 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 3; n=23, 22, 18 | 24.8 units on a scale | Standard Deviation 19.5 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 30.9 units on a scale | Standard Deviation 17.3 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 30; n=22, 16, 12 | 33.9 units on a scale | Standard Deviation 16.8 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 6; n=25, 20, 18 | 31.3 units on a scale | Standard Deviation 15.2 |
| Duodopa Naïve | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 39.4 units on a scale | Standard Deviation 17.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 34.8 units on a scale | Standard Deviation 20.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 27.1 units on a scale | Standard Deviation 19.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 3; n=23, 22, 18 | 27.5 units on a scale | Standard Deviation 19.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 6; n=25, 20, 18 | 33.3 units on a scale | Standard Deviation 18.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 32.1 units on a scale | Standard Deviation 17 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 30.2 units on a scale | Standard Deviation 19.5 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 37.7 units on a scale | Standard Deviation 19 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 30; n=22, 16, 12 | 33.3 units on a scale | Standard Deviation 25.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 30.0 units on a scale | Standard Deviation 21 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 31.1 units on a scale | Standard Deviation 24.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 38.6 units on a scale | Standard Deviation 19.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 33.1 units on a scale | Standard Deviation 16.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 3; n=23, 22, 18 | 35.4 units on a scale | Standard Deviation 21.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 30; n=22, 16, 12 | 31.3 units on a scale | Standard Deviation 18.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 37.7 units on a scale | Standard Deviation 17 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 38.0 units on a scale | Standard Deviation 23.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 34.8 units on a scale | Standard Deviation 18.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 39.7 units on a scale | Standard Deviation 21.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 32.6 units on a scale | Standard Deviation 22.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Emotional Well Being Subscale Scores From Baseline to Month 36 | Month 6; n=25, 20, 18 | 35.9 units on a scale | Standard Deviation 20 |
Secondary
PDQ-39 Mobility Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 46.0 units on a scale | Standard Deviation 22.2 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 9; n=24, 20, 17 | 40.2 units on a scale | Standard Deviation 15.6 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 57.3 units on a scale | Standard Deviation 20.8 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 18; n=24, 18, 16 | 40.9 units on a scale | Standard Deviation 16.2 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 41.0 units on a scale | Standard Deviation 18.3 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 55.7 units on a scale | Standard Deviation 20.5 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 3; n=23, 20, 18 | 36.0 units on a scale | Standard Deviation 17.6 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 38.8 units on a scale | Standard Deviation 20.1 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 50.9 units on a scale | Standard Deviation 21.5 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 39.5 units on a scale | Standard Deviation 18.9 |
| Duodopa Naïve | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 21, 17 | 55.6 units on a scale | Standard Deviation 20.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 45.3 units on a scale | Standard Deviation 24.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 43.9 units on a scale | Standard Deviation 21.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 3; n=23, 20, 18 | 40.6 units on a scale | Standard Deviation 22.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 43.5 units on a scale | Standard Deviation 23.5 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 9; n=24, 20, 17 | 41.9 units on a scale | Standard Deviation 21.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 18; n=24, 18, 16 | 41.1 units on a scale | Standard Deviation 25.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 47.1 units on a scale | Standard Deviation 21.5 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 42.1 units on a scale | Standard Deviation 21.5 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 43.0 units on a scale | Standard Deviation 21.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 21, 17 | 50.2 units on a scale | Standard Deviation 22.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 61.1 units on a scale | Standard Deviation 28.1 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 49.5 units on a scale | Standard Deviation 23 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 3; n=23, 20, 18 | 50.6 units on a scale | Standard Deviation 24.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 53.3 units on a scale | Standard Deviation 24.8 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 53.3 units on a scale | Standard Deviation 22.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 12; n=25, 20, 17 | 54.4 units on a scale | Standard Deviation 32.1 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 9; n=24, 20, 17 | 52.8 units on a scale | Standard Deviation 23 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 21, 17 | 61.6 units on a scale | Standard Deviation 25 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 18; n=24, 18, 16 | 54.7 units on a scale | Standard Deviation 29.2 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Mobility Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 54.7 units on a scale | Standard Deviation 24.4 |
Secondary
PDQ-39 Social Support Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 18; n=22, 20, 16 | 12.7 units on a scale | Standard Deviation 15.6 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 17 | 10.3 units on a scale | Standard Deviation 18.2 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 18.3 units on a scale | Standard Deviation 21 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 14 | 15.7 units on a scale | Standard Deviation 18.5 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 9; n=24, 20, 16 | 10.2 units on a scale | Standard Deviation 16.3 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 18.2 units on a scale | Standard Deviation 24.8 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 12.7 units on a scale | Standard Deviation 18 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27,0,0 | 8.3 units on a scale | Standard Deviation 15.9 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 12; n=23, 20, 17 | 12.1 units on a scale | Standard Deviation 19.5 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 10.8 units on a scale | Standard Deviation 15.2 |
| Duodopa Naïve | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 21.8 units on a scale | Standard Deviation 25.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 12.5 units on a scale | Standard Deviation 18.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 13.1 units on a scale | Standard Deviation 14.1 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 9; n=24, 20, 16 | 13.8 units on a scale | Standard Deviation 14.9 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 12; n=23, 20, 17 | 19.6 units on a scale | Standard Deviation 19.4 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 18; n=22, 20, 16 | 17.9 units on a scale | Standard Deviation 19.4 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 14 | 20.6 units on a scale | Standard Deviation 18.7 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 16.2 units on a scale | Standard Deviation 20.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 11.7 units on a scale | Standard Deviation 13.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 14.4 units on a scale | Standard Deviation 18.9 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27,0,0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 17 | 12.9 units on a scale | Standard Deviation 14.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 29.5 units on a scale | Standard Deviation 26.7 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 12; n=23, 20, 17 | 28.4 units on a scale | Standard Deviation 22.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 16.7 units on a scale | Standard Deviation 19.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 27.9 units on a scale | Standard Deviation 25.3 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 9; n=24, 20, 16 | 25.5 units on a scale | Standard Deviation 18.1 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 17 | 22.1 units on a scale | Standard Deviation 19.1 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 14 | 21.7 units on a scale | Standard Deviation 15.7 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27,0,0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 30; n=22, 17, 12 | 18.8 units on a scale | Standard Deviation 22.8 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 18; n=22, 20, 16 | 18.8 units on a scale | Standard Deviation 18.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Social Support Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 17 | 24.3 units on a scale | Standard Deviation 21.5 |
Secondary
PDQ-39 Stigma Subscale Scores From Baseline to Month 36
The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 15.8 units on a scale | Standard Deviation 12.4 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 15.5 units on a scale | Standard Deviation 15.7 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 20.5 units on a scale | Standard Deviation 19.1 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 15.6 units on a scale | Standard Deviation 17.5 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 12; n=25, 19, 17 | 17.8 units on a scale | Standard Deviation 17 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 24.8 units on a scale | Standard Deviation 15.4 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 16.1 units on a scale | Standard Deviation 15 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 16.2 units on a scale | Standard Deviation 16.8 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 30; n=21, 17, 12 | 16.4 units on a scale | Standard Deviation 18.6 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 20.8 units on a scale | Standard Deviation 16.2 |
| Duodopa Naïve | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 19.5 units on a scale | Standard Deviation 18.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 13.8 units on a scale | Standard Deviation 15.1 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 16.5 units on a scale | Standard Deviation 18.5 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 18.8 units on a scale | Standard Deviation 23.8 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 19.0 units on a scale | Standard Deviation 19.3 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 12.8 units on a scale | Standard Deviation 15.1 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 12; n=25, 19, 17 | 19.4 units on a scale | Standard Deviation 19.9 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 23.5 units on a scale | Standard Deviation 19.2 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 30; n=21, 17, 12 | 14.0 units on a scale | Standard Deviation 23.6 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 12.9 units on a scale | Standard Deviation 20 |
| Duodopa Non-naïve < 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 15.6 units on a scale | Standard Deviation 20.3 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 36; n=21, 15, 11 | 24.4 units on a scale | Standard Deviation 19.3 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 24; n=21, 17, 15 | 15.4 units on a scale | Standard Deviation 14.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 3; n=24, 22, 18 | 19.8 units on a scale | Standard Deviation 17.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA units on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 30; n=21, 17, 12 | 18.2 units on a scale | Standard Deviation 21.4 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 0; n=27, 22, 18 | 22.9 units on a scale | Standard Deviation 23 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Endpoint; n=26, 22, 17 | 25.0 units on a scale | Standard Deviation 23.8 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 12; n=25, 19, 17 | 25.4 units on a scale | Standard Deviation 25.5 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 9; n=25, 20, 17 | 24.6 units on a scale | Standard Deviation 23.6 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 18; n=24, 20, 16 | 18.8 units on a scale | Standard Deviation 22 |
| Duodopa Non-naïve ≥ 2 Years | PDQ-39 Stigma Subscale Scores From Baseline to Month 36 | Month 6; n=25, 21, 18 | 23.6 units on a scale | Standard Deviation 24.4 |
Secondary
Schwab and England Scale: Best On Period Stage From Baseline to Month 36
The Schwab and England scale was used to rate the subject's best on period during the past week by recording the percentage score, ranging between being completely independent (100%) and totally dependent (10%). On time is when PD symptoms are well controlled by the drug.
Time frame: Baseline (Month -3), Months 0, 3, 6, 9, 12, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 72.2 percentage score on a scale | Standard Deviation 18.1 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 79.2 percentage score on a scale | Standard Deviation 13.5 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 66.7 percentage score on a scale | Standard Deviation 21.1 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 75.8 percentage score on a scale | Standard Deviation 12.8 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 77.2 percentage score on a scale | Standard Deviation 13.4 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | 74.4 percentage score on a scale | Standard Deviation 15.8 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 77.9 percentage score on a scale | Standard Deviation 14.4 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 80.4 percentage score on a scale | Standard Deviation 13.2 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 70.4 percentage score on a scale | Standard Deviation 18.7 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 75.2 percentage score on a scale | Standard Deviation 15.3 |
| Duodopa Naïve | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 68.9 percentage score on a scale | Standard Deviation 19.5 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 72.5 percentage score on a scale | Standard Deviation 15.9 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA percentage score on a scale | — |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 75.5 percentage score on a scale | Standard Deviation 14.4 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 75.9 percentage score on a scale | Standard Deviation 14.4 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 77.3 percentage score on a scale | Standard Deviation 11.6 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 76.5 percentage score on a scale | Standard Deviation 13.1 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 74.0 percentage score on a scale | Standard Deviation 11.9 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 73.3 percentage score on a scale | Standard Deviation 14.6 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 71.8 percentage score on a scale | Standard Deviation 16.7 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 73.1 percentage score on a scale | Standard Deviation 13 |
| Duodopa Non-naïve < 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 71.4 percentage score on a scale | Standard Deviation 13.2 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 36; n=21, 16, 12 | 64.2 percentage score on a scale | Standard Deviation 21.1 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 24; n=23, 18, 15 | 68.0 percentage score on a scale | Standard Deviation 15.2 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 3; n=24, 22, 18 | 72.2 percentage score on a scale | Standard Deviation 15.2 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Baseline (Month -3); n=27, 0, 0 | NA percentage score on a scale | — |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 30; n=23, 17, 13 | 67.7 percentage score on a scale | Standard Deviation 17.9 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 0; n=27, 22, 18 | 74.4 percentage score on a scale | Standard Deviation 11.5 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 12; n=25, 20, 17 | 71.8 percentage score on a scale | Standard Deviation 12.4 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 9; n=25, 20, 17 | 70.6 percentage score on a scale | Standard Deviation 13 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Endpoint; n=27, 22, 18 | 62.2 percentage score on a scale | Standard Deviation 17.7 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 18; n=24, 20, 17 | 69.4 percentage score on a scale | Standard Deviation 14.3 |
| Duodopa Non-naïve ≥ 2 Years | Schwab and England Scale: Best On Period Stage From Baseline to Month 36 | Month 6; n=25, 22, 18 | 72.2 percentage score on a scale | Standard Deviation 12.6 |
Other Pre-specified
EQ-5D Descriptive Systems Summary Index Score, up to Month 36
The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.
Time frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Endpoint visit; n=26, 22, 17 | 0.54 units on a scale | Standard Deviation 0.31 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 30; n=22, 17, 12 | 0.55 units on a scale | Standard Deviation 0.28 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 3; n=24, 22, 18 | 0.61 units on a scale | Standard Deviation 0.3 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 9; n=25, 20, 17 | 0.61 units on a scale | Standard Deviation 0.33 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 36; n=21, 15, 11 | 0.52 units on a scale | Standard Deviation 0.31 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 6; n=25, 21, 18 | 0.64 units on a scale | Standard Deviation 0.26 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 0; n=27, 22, 18 | 0.67 units on a scale | Standard Deviation 0.27 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 18; n=24, 20, 16 | 0.64 units on a scale | Standard Deviation 0.23 |
| Duodopa Naïve | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 24; n=21, 18, 15 | 0.58 units on a scale | Standard Deviation 0.33 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 24; n=21, 18, 15 | 0.67 units on a scale | Standard Deviation 0.26 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 6; n=25, 21, 18 | 0.71 units on a scale | Standard Deviation 0.22 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 30; n=22, 17, 12 | 0.69 units on a scale | Standard Deviation 0.19 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 18; n=24, 20, 16 | 0.66 units on a scale | Standard Deviation 0.34 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 9; n=25, 20, 17 | 0.66 units on a scale | Standard Deviation 0.23 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 3; n=24, 22, 18 | 0.70 units on a scale | Standard Deviation 0.29 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 0; n=27, 22, 18 | 0.68 units on a scale | Standard Deviation 0.27 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 36; n=21, 15, 11 | 0.57 units on a scale | Standard Deviation 0.28 |
| Duodopa Non-naïve < 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Endpoint visit; n=26, 22, 17 | 0.60 units on a scale | Standard Deviation 0.25 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Endpoint visit; n=26, 22, 17 | 0.46 units on a scale | Standard Deviation 0.33 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 0; n=27, 22, 18 | 0.62 units on a scale | Standard Deviation 0.24 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 3; n=24, 22, 18 | 0.57 units on a scale | Standard Deviation 0.32 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 6; n=25, 21, 18 | 0.57 units on a scale | Standard Deviation 0.32 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 9; n=25, 20, 17 | 0.59 units on a scale | Standard Deviation 0.3 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 24; n=21, 18, 15 | 0.47 units on a scale | Standard Deviation 0.32 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 30; n=22, 17, 12 | 0.52 units on a scale | Standard Deviation 0.28 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 18; n=24, 20, 16 | 0.53 units on a scale | Standard Deviation 0.35 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Descriptive Systems Summary Index Score, up to Month 36 | Month 36; n=21, 15, 11 | 0.51 units on a scale | Standard Deviation 0.25 |
Other Pre-specified
EQ-5D Visual Analog Scale (VAS) Score, up to Month 36
The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'
Time frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 0; n=27, 22, 18 | 0.68 units on a scale | Standard Deviation 0.18 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 30; n=22, 17, 12 | 0.56 units on a scale | Standard Deviation 0.2 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 18; n=24, 20, 16 | 0.62 units on a scale | Standard Deviation 0.2 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Endpoint visit; n=26, 22, 17 | 0.57 units on a scale | Standard Deviation 0.16 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 24; n=21, 17, 15 | 0.64 units on a scale | Standard Deviation 0.18 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 6; n=25, 21, 18 | 0.60 units on a scale | Standard Deviation 0.22 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 3; n=24, 22, 18 | 0.65 units on a scale | Standard Deviation 0.19 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 36; n=21, 15, 11 | 0.56 units on a scale | Standard Deviation 0.17 |
| Duodopa Naïve | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 9; n=25, 20, 17 | 0.68 units on a scale | Standard Deviation 0.14 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 0; n=27, 22, 18 | 0.65 units on a scale | Standard Deviation 0.18 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 3; n=24, 22, 18 | 0.63 units on a scale | Standard Deviation 0.18 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 6; n=25, 21, 18 | 0.65 units on a scale | Standard Deviation 0.16 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 9; n=25, 20, 17 | 0.69 units on a scale | Standard Deviation 0.15 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 18; n=24, 20, 16 | 0.60 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 24; n=21, 17, 15 | 0.60 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 30; n=22, 17, 12 | 0.67 units on a scale | Standard Deviation 0.14 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 36; n=21, 15, 11 | 0.61 units on a scale | Standard Deviation 0.18 |
| Duodopa Non-naïve < 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Endpoint visit; n=26, 22, 17 | 0.61 units on a scale | Standard Deviation 0.17 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 0; n=27, 22, 18 | 0.58 units on a scale | Standard Deviation 0.23 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 30; n=22, 17, 12 | 0.65 units on a scale | Standard Deviation 0.17 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 6; n=25, 21, 18 | 0.59 units on a scale | Standard Deviation 0.18 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Endpoint visit; n=26, 22, 17 | 0.57 units on a scale | Standard Deviation 0.21 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 36; n=21, 15, 11 | 0.62 units on a scale | Standard Deviation 0.19 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 18; n=24, 20, 16 | 0.55 units on a scale | Standard Deviation 0.27 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 3; n=24, 22, 18 | 0.58 units on a scale | Standard Deviation 0.2 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 24; n=21, 17, 15 | 0.63 units on a scale | Standard Deviation 0.12 |
| Duodopa Non-naïve ≥ 2 Years | EQ-5D Visual Analog Scale (VAS) Score, up to Month 36 | Month 9; n=25, 20, 17 | 0.58 units on a scale | Standard Deviation 0.19 |
Other Pre-specified
UPDRS Part III Score, up to Month 36
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Higher scores are associated with more disability.
Time frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 3; n=24, 22, 18 | 21.6 units on a scale | Standard Deviation 11.5 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 30; n=23, 17, 13 | 23.1 units on a scale | Standard Deviation 15.6 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 9; n=25, 20, 17 | 19.9 units on a scale | Standard Deviation 12.4 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 6; n=25, 20, 18 | 21.5 units on a scale | Standard Deviation 14.1 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 36; n=21, 16, 12 | 22.0 units on a scale | Standard Deviation 17.2 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 24; n=23, 18, 15 | 21.4 units on a scale | Standard Deviation 14.2 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 0; n=27, 22, 18 | 22.0 units on a scale | Standard Deviation 9.7 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Endpoint visit; n=27, 22, 17 | 23.1 units on a scale | Standard Deviation 15.8 |
| Duodopa Naïve | UPDRS Part III Score, up to Month 36 | Month 18; n=24, 20, 16 | 21.3 units on a scale | Standard Deviation 12.6 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 6; n=25, 20, 18 | 22.8 units on a scale | Standard Deviation 9.9 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 36; n=21, 16, 12 | 22.2 units on a scale | Standard Deviation 7.9 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Endpoint visit; n=27, 22, 17 | 24.1 units on a scale | Standard Deviation 9.8 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 0; n=27, 22, 18 | 23.4 units on a scale | Standard Deviation 11.1 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 3; n=24, 22, 18 | 22.9 units on a scale | Standard Deviation 11.3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 9; n=25, 20, 17 | 21.9 units on a scale | Standard Deviation 8.1 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 18; n=24, 20, 16 | 21.7 units on a scale | Standard Deviation 9.3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 24; n=23, 18, 15 | 18.2 units on a scale | Standard Deviation 9.8 |
| Duodopa Non-naïve < 2 Years | UPDRS Part III Score, up to Month 36 | Month 30; n=23, 17, 13 | 22.6 units on a scale | Standard Deviation 11.5 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 0; n=27, 22, 18 | 22.4 units on a scale | Standard Deviation 9.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 36; n=21, 16, 12 | 28.0 units on a scale | Standard Deviation 15.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 18; n=24, 20, 16 | 23.3 units on a scale | Standard Deviation 11.1 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Endpoint visit; n=27, 22, 17 | 28.6 units on a scale | Standard Deviation 13.6 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 30; n=23, 17, 13 | 24.0 units on a scale | Standard Deviation 12.1 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 6; n=25, 20, 18 | 22.6 units on a scale | Standard Deviation 8.6 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 3; n=24, 22, 18 | 21.9 units on a scale | Standard Deviation 9.5 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 24; n=23, 18, 15 | 25.4 units on a scale | Standard Deviation 9.2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part III Score, up to Month 36 | Month 9; n=25, 20, 17 | 22.9 units on a scale | Standard Deviation 11.8 |
Other Pre-specified
UPDRS Part II Score, up to Month 36
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Higher scores are associated with more disability.
Time frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 30; n=23, 17, 13 | 14.0 units on a scale | Standard Deviation 8.5 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 24; n=23, 18, 15 | 12.9 units on a scale | Standard Deviation 7.7 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 9; n=25, 20, 17 | 11.8 units on a scale | Standard Deviation 6.9 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 3; n=24, 22, 18 | 12.0 units on a scale | Standard Deviation 5.7 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 18; n=24, 20, 17 | 13.3 units on a scale | Standard Deviation 7.2 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 0; n=27, 22, 18 | 12.3 units on a scale | Standard Deviation 5.1 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Endpoint visit; n=27, 22, 18 | 14.6 units on a scale | Standard Deviation 7.9 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 6; n=25, 22, 18 | 12.4 units on a scale | Standard Deviation 6.7 |
| Duodopa Naïve | UPDRS Part II Score, up to Month 36 | Month 36; n=21, 16, 12 | 13.9 units on a scale | Standard Deviation 8.4 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 30; n=23, 17, 13 | 14.6 units on a scale | Standard Deviation 7.3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 0; n=27, 22, 18 | 13.7 units on a scale | Standard Deviation 6.3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 3; n=24, 22, 18 | 12.8 units on a scale | Standard Deviation 7.1 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 6; n=25, 22, 18 | 13.4 units on a scale | Standard Deviation 6.7 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 9; n=25, 20, 17 | 13.0 units on a scale | Standard Deviation 5.5 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 18; n=24, 20, 17 | 12.9 units on a scale | Standard Deviation 6.6 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 24; n=23, 18, 15 | 12.2 units on a scale | Standard Deviation 6.2 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Month 36; n=21, 16, 12 | 14.6 units on a scale | Standard Deviation 5.4 |
| Duodopa Non-naïve < 2 Years | UPDRS Part II Score, up to Month 36 | Endpoint visit; n=27, 22, 18 | 15.7 units on a scale | Standard Deviation 6.4 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 0; n=27, 22, 18 | 15.4 units on a scale | Standard Deviation 5.9 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 24; n=23, 18, 15 | 17.2 units on a scale | Standard Deviation 5.3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 30; n=23, 17, 13 | 16.9 units on a scale | Standard Deviation 6.3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Endpoint visit; n=27, 22, 18 | 17.3 units on a scale | Standard Deviation 7 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 36; n=21, 16, 12 | 16.8 units on a scale | Standard Deviation 8.2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 9; n=25, 20, 17 | 14.4 units on a scale | Standard Deviation 5.2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 3; n=24, 22, 18 | 15.0 units on a scale | Standard Deviation 5.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 18; n=24, 20, 17 | 15.6 units on a scale | Standard Deviation 5.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part II Score, up to Month 36 | Month 6; n=25, 22, 18 | 14.3 units on a scale | Standard Deviation 4.4 |
Other Pre-specified
UPDRS Part I Score, up to Month 36
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Higher scores are associated with more disability.
Time frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 9; n=25, 20, 17 | 3.0 units on a scale | Standard Deviation 1.9 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Endpoint visit; n=27, 22, 18 | 3.9 units on a scale | Standard Deviation 3.2 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 24; n=23, 18, 15 | 3.9 units on a scale | Standard Deviation 2.8 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 18; n=24, 20, 17 | 4.1 units on a scale | Standard Deviation 3 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 0; n=27, 22, 18 | 2.4 units on a scale | Standard Deviation 1.8 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 36; n=21, 16, 12 | 3.9 units on a scale | Standard Deviation 3.1 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 6; n=25, 22, 18 | 2.9 units on a scale | Standard Deviation 1.9 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 3; n=24, 22, 18 | 2.5 units on a scale | Standard Deviation 1.7 |
| Duodopa Naïve | UPDRS Part I Score, up to Month 36 | Month 30; n=23, 17, 13 | 4.1 units on a scale | Standard Deviation 3.2 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 18; n=24, 20, 17 | 2.7 units on a scale | Standard Deviation 2.2 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 0; n=27, 22, 18 | 2.0 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 3; n=24, 22, 18 | 2.0 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 6; n=25, 22, 18 | 2.3 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 9; n=25, 20, 17 | 2.9 units on a scale | Standard Deviation 1.6 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 24; n=23, 18, 15 | 3.0 units on a scale | Standard Deviation 2 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 30; n=23, 17, 13 | 3.5 units on a scale | Standard Deviation 2.7 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Month 36; n=21, 16, 12 | 3.9 units on a scale | Standard Deviation 2.5 |
| Duodopa Non-naïve < 2 Years | UPDRS Part I Score, up to Month 36 | Endpoint visit; n=27, 22, 18 | 3.5 units on a scale | Standard Deviation 2.6 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 6; n=25, 22, 18 | 2.9 units on a scale | Standard Deviation 2.1 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 0; n=27, 22, 18 | 2.7 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 30; n=23, 17, 13 | 2.8 units on a scale | Standard Deviation 2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 3; n=24, 22, 18 | 3.2 units on a scale | Standard Deviation 2.3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Endpoint visit; n=27, 22, 18 | 4.0 units on a scale | Standard Deviation 2.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 18; n=24, 20, 17 | 3.3 units on a scale | Standard Deviation 2.6 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 9; n=25, 20, 17 | 3.3 units on a scale | Standard Deviation 2.3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 36; n=21, 16, 12 | 3.8 units on a scale | Standard Deviation 3.3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part I Score, up to Month 36 | Month 24; n=23, 18, 15 | 3.5 units on a scale | Standard Deviation 2.1 |
Other Pre-specified
UPDRS Part IV Score, up to Month 36
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Part IV, questions are measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect) or 2-point scale (0 or 1). Part IV score is the sum of answers to 'Complications of Therapy' questions, with a score range from 0-23. Higher scores are associated with more disability.
Time frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 0; n=27, 22, 18 | 6.5 units on a scale | Standard Deviation 2.7 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 3; n=24, 22, 18 | 6.3 units on a scale | Standard Deviation 2.9 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 18; n=24, 20, 17 | 6.5 units on a scale | Standard Deviation 3.3 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 6; n=25, 22, 18 | 6.5 units on a scale | Standard Deviation 2.7 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 9; n=25, 20, 17 | 6.1 units on a scale | Standard Deviation 3.3 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 36; n=21, 16, 12 | 6.4 units on a scale | Standard Deviation 3 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 24; n=23, 18, 15 | 6.3 units on a scale | Standard Deviation 4.3 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Month 30; n=22, 17, 13 | 6.2 units on a scale | Standard Deviation 3.7 |
| Duodopa Naïve | UPDRS Part IV Score, up to Month 36 | Endpoint visit; n=26, 22, 18 | 6.5 units on a scale | Standard Deviation 3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 6; n=25, 22, 18 | 7.1 units on a scale | Standard Deviation 2.8 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Endpoint visit; n=26, 22, 18 | 7.5 units on a scale | Standard Deviation 3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 9; n=25, 20, 17 | 7.3 units on a scale | Standard Deviation 3.3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 36; n=21, 16, 12 | 6.4 units on a scale | Standard Deviation 2.4 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 30; n=22, 17, 13 | 6.6 units on a scale | Standard Deviation 3.3 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 24; n=23, 18, 15 | 6.8 units on a scale | Standard Deviation 3.6 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 0; n=27, 22, 18 | 7.1 units on a scale | Standard Deviation 3.4 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 3; n=24, 22, 18 | 7.8 units on a scale | Standard Deviation 3.1 |
| Duodopa Non-naïve < 2 Years | UPDRS Part IV Score, up to Month 36 | Month 18; n=24, 20, 17 | 7.0 units on a scale | Standard Deviation 3.2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 30; n=22, 17, 13 | 6.5 units on a scale | Standard Deviation 2.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 6; n=25, 22, 18 | 7.7 units on a scale | Standard Deviation 3.2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 36; n=21, 16, 12 | 5.5 units on a scale | Standard Deviation 1.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 0; n=27, 22, 18 | 7.2 units on a scale | Standard Deviation 3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 9; n=25, 20, 17 | 7.5 units on a scale | Standard Deviation 4.2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Endpoint visit; n=26, 22, 18 | 6.7 units on a scale | Standard Deviation 2.7 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 24; n=23, 18, 15 | 6.6 units on a scale | Standard Deviation 2.5 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 18; n=24, 20, 17 | 7.6 units on a scale | Standard Deviation 2.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Part IV Score, up to Month 36 | Month 3; n=24, 22, 18 | 6.7 units on a scale | Standard Deviation 3.4 |
Other Pre-specified
UPDRS Total Score up to Month 36
The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. For Parts I-III and Total Score, each question is measured on a 5-point scale of 0 (normal or no disease effect) to 4 (maximum negative effect). Part I score is the sum of answers to 'Mentation, Behavior and Mood' questions, with a score range from 0-16. Part II score is the sum of answers to 'Activities of Daily Living' questions, with a score range from 0-52. Part III score is the sum of answers to 'Motor Examination' questions, with a score range from 0-108. Total Score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale, with a score range from 0-176. Higher scores are associated with more disability.
Time frame: Months 0, 3, 6, 9, 18, 24, 30, 36, endpoint (last non-missing value assigned to treatment for the participant)
Population: Full Analysis Set: Participants who had ≥1 dose of study drug and (for Duodopa naives) data for baseline (BL) and ≥1 post-BL assessment of the primary efficacy measurements UPDRS and EQ-5D or (for Duodopa non-naives) had data for Month 0 visit and ≥1 more assessment of UPDRS and EQ-5D. n=participants with assessments at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 9; 5, 20, 17 | 40.8 units on a scale | Standard Deviation 22.4 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 0; n=27, 22, 18 | 43.1 units on a scale | Standard Deviation 16.7 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 30; n=23, 17, 13 | 47.1 units on a scale | Standard Deviation 25.5 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 18; n=24, 20, 17 | 45.2 units on a scale | Standard Deviation 22.8 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Endpoint visit; n=27, 22, 18 | 47.9 units on a scale | Standard Deviation 25.8 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 24; n=23, 18, 15 | 44.5 units on a scale | Standard Deviation 25.3 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 6; n=25, 22, 18 | 43.3 units on a scale | Standard Deviation 21.4 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 3; n=24, 22, 18 | 42.4 units on a scale | Standard Deviation 19.1 |
| Duodopa Naïve | UPDRS Total Score up to Month 36 | Month 36; n=21, 16, 12 | 46.2 units on a scale | Standard Deviation 27.8 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Endpoint visit; n=27, 22, 18 | 50.8 units on a scale | Standard Deviation 17.5 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 0; n=27, 22, 18 | 46.2 units on a scale | Standard Deviation 17.3 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 3; n=24, 22, 18 | 45.5 units on a scale | Standard Deviation 18.2 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 6; n=25, 22, 18 | 43.5 units on a scale | Standard Deviation 17.6 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 9; 5, 20, 17 | 45.1 units on a scale | Standard Deviation 13 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 18; n=24, 20, 17 | 44.2 units on a scale | Standard Deviation 16.1 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 24; n=23, 18, 15 | 40.2 units on a scale | Standard Deviation 15.9 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 30; n=23, 17, 13 | 47.4 units on a scale | Standard Deviation 19 |
| Duodopa Non-naïve < 2 Years | UPDRS Total Score up to Month 36 | Month 36; n=21, 16, 12 | 47.1 units on a scale | Standard Deviation 14.3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 9; 5, 20, 17 | 48.1 units on a scale | Standard Deviation 17.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Endpoint visit; n=27, 22, 18 | 55.0 units on a scale | Standard Deviation 23 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 3; n=24, 22, 18 | 46.8 units on a scale | Standard Deviation 16.4 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 30; n=23, 17, 13 | 50.2 units on a scale | Standard Deviation 19.8 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 6; n=25, 22, 18 | 47.4 units on a scale | Standard Deviation 13.2 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 0; n=27, 22, 18 | 47.8 units on a scale | Standard Deviation 16.4 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 18; n=24, 20, 17 | 48.5 units on a scale | Standard Deviation 18 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 36; n=21, 16, 12 | 54.0 units on a scale | Standard Deviation 25.3 |
| Duodopa Non-naïve ≥ 2 Years | UPDRS Total Score up to Month 36 | Month 24; n=23, 18, 15 | 52.7 units on a scale | Standard Deviation 15.5 |