Parkinson Disease
Conditions
Brief summary
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease
Interventions
DRUGpramipexole
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation; * Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia); * Parkinsons disease newly diagnosed within the past 2 years; * Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1); * Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
* Previous history of allergic response or complications with pramipexole (PPX) or its excipients; * Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy); * The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline; * The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline; * If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline; * The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease; * The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease; * The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery); * History of stereotactic brain surgery; * Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study; * History of active epilepsy (i.e., occurrence of a seizure) within the past year; * Symptomatic orthostatic hypotension prior to randomization; * Malignant melanoma or history of previously treated malignant melanoma; * Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine; * Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1); * Patients who are currently pregnant or planning pregnancy during the study, or lactating; * Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization; * History of psychosis; * A diagnosis of dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 | Baseline and Month 15 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9 | Baseline and Month 9 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6 | Baseline and Month 6 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3 | Baseline and Month 3 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) |
| Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15 | Baseline and Month 15 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15 | Baseline and Month 15 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9 | Baseline and Month 9 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6 | Baseline and Month 6 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3 | Baseline and Month 3 | The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability) |
| Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15 | Baseline and Month 15 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15 | Baseline and Month 15 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9 | Baseline and Month 9 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6 | Baseline and Month 6 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3 | Baseline and Month 3 | The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability) |
| Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15 | Baseline and Month 15 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15 | Baseline and Month 15 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9 | Baseline and Month 9 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6 | Baseline and Month 6 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3 | Baseline and Month 3 | The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability) |
| Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15 | Baseline and Month 15 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15 | Baseline and Month 15 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9 | Baseline and Month 9 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6 | Baseline and Month 6 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) |
| Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3 | Baseline and Month 3 | The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability) |
| Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15 | Month 15 | The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2. |
| Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | Baseline and Month 15 | The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (\>1 category improvement), 'Unchanged' or 'Worsened' (\>1 category worsening). |
| Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15 | Baseline and Month 15 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) |
| Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9 | Baseline and Month 9 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) |
| Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6 | Baseline and Month 6 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) |
| Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3 | Baseline and Month 3 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) |
| Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15 | Baseline and Month 15 | The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) |
| Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9 | Baseline and Month 9 | The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) |
| Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15 | Baseline and Month 15 | The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) |
| Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9 | Baseline and Month 9 | The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) |
| Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15 | Baseline and Month 15 | The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state) |
| Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9 | Baseline and Month 9 | The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state) |
| Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 | Month 1 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. |
| Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 | Month 6 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. |
| Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 | Month 9 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. |
| Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 | Month 12 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. |
| Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 | Month 15 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 | Month 1 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 | Month 6 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 | Month 9 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 | Month 12 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 | Month 15 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 | Month 1 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 | Month 6 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 | Month 9 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. |
| Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15 | Baseline and Month 15 | The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability) |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 | Month 15 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. |
| Percentage Change From Baseline in the Striatum Uptake at Month 15 | Baseline and Month 15 | The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT). |
| Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Baseline and Month 15 | — |
| Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes | Baseline and Month 15 | — |
| Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Baseline and Month 15 | — |
| Clinically Significant Abnormalities in Vital Signs | Baseline and Month 15 | — |
| Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 | Month 12 | The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a. |
Countries
Austria, Finland, France, Germany, Italy, Japan, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early Pramipexole 1.5 milligrams/day pramipexole (for up to 15 months) | 261 |
| Delayed Pramipexole Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months) | 274 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 41 | 43 |
| Overall Study | Lack of Efficacy | 9 | 14 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Protocol Violation | 6 | 5 |
| Overall Study | Withdrawal by Subject | 6 | 17 |
Baseline characteristics
| Characteristic | Early Pramipexole | Delayed Pramipexole | Total |
|---|---|---|---|
| Age, Continuous | 62.1 Years STANDARD_DEVIATION 10.1 | 62.9 Years STANDARD_DEVIATION 9.9 | 62.5 Years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 84 Participants | 108 Participants | 192 Participants |
| Sex: Female, Male Male | 177 Participants | 166 Participants | 343 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 172 / 261 | 164 / 274 |
| serious Total, serious adverse events | 25 / 261 | 25 / 274 |
Outcome results
Primary
Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time frame: Baseline and Month 15
Population: The Phase 2 Full Analysis Set (FAS2) was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 | 0.3 Units on a scale | Standard Error 0.7 |
| Delayed Pramipexole | Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15 | 0.7 Units on a scale | Standard Error 0.7 |
p-value: 0.650395% CI: [-2.2, 1.4]ANCOVA
Secondary
Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15
The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (\>1 category improvement), 'Unchanged' or 'Worsened' (\>1 category worsening).
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 4 patients from the FAS2 were excluded due to insufficient CGI-I data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | Improved | 4 Participants |
| Early Pramipexole | Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | Essentially unchanged | 200 Participants |
| Early Pramipexole | Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | Worsened | 5 Participants |
| Delayed Pramipexole | Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | Improved | 3 Participants |
| Delayed Pramipexole | Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | Essentially unchanged | 191 Participants |
| Delayed Pramipexole | Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15 | Worsened | 4 Participants |
Comparison: The ordinal responses (3 levels) were analysed using the proportional odds model extension of logistic regressionp-value: 0.791395% CI: [0.403, 3.299]Regression, Logistic
Secondary
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient BDI data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15 | -1 Units on a scale | Standard Error 0.3 |
| Delayed Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15 | -0.5 Units on a scale | Standard Error 0.3 |
p-value: 0.170295% CI: [-1.3, 0.2]ANCOVA
Secondary
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time frame: Baseline and Month 3
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3 | -1 Units on a scale | Standard Error 0.3 |
| Delayed Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3 | -0.3 Units on a scale | Standard Error 0.3 |
p-value: 0.042295% CI: [-1.4, 0]ANCOVA
Secondary
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time frame: Baseline and Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6 | -1.2 Units on a scale | Standard Error 0.3 |
| Delayed Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6 | 0.2 Units on a scale | Standard Error 0.3 |
p-value: 0.000595% CI: [-2.1, -0.6]ANCOVA
Secondary
Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9
The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9 | -1.1 Units on a scale | Standard Error 0.3 |
| Delayed Pramipexole | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9 | 0.3 Units on a scale | Standard Error 0.3 |
p-value: 0.000995% CI: [-2.2, -0.6]ANCOVA
Secondary
Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15 | 0.1 Units on a scale | Standard Error 0.5 |
| Delayed Pramipexole | Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15 | 0.3 Units on a scale | Standard Error 0.5 |
p-value: 0.799995% CI: [-1.5, 1.1]ANCOVA
Secondary
Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15 | 0.5 Units on a scale | Standard Error 0.2 |
| Delayed Pramipexole | Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15 | 0.4 Units on a scale | Standard Error 0.2 |
p-value: 0.925695% CI: [-0.6, 0.6]ANCOVA
Secondary
Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15 | -0.3 Units on a scale | Standard Error 0.1 |
| Delayed Pramipexole | Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15 | 0 Units on a scale | Standard Error 0.1 |
p-value: 0.037695% CI: [-0.5, 0]ANCOVA
Secondary
Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15 | 0.6 Units on a scale | Standard Error 0.7 |
| Delayed Pramipexole | Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15 | 0.7 Units on a scale | Standard Error 0.7 |
p-value: 0.869395% CI: [-1.8, 1.5]ANCOVA
Secondary
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15 | 0 Units on a scale | Inter-Quartile Range 0 |
| Delayed Pramipexole | Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15 | 0 Units on a scale | Inter-Quartile Range 0 |
p-value: 0.260595% CI: [0, 0.026]Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9
The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9 | 0 Units on a scale | Inter-Quartile Range 0 |
| Delayed Pramipexole | Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9 | 0 Units on a scale | Inter-Quartile Range 0 |
p-value: <0.000195% CI: [0, 0.089]Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 2 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15 | 0 Units on a scale | Inter-Quartile Range 0 |
| Delayed Pramipexole | Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15 | 0 Units on a scale | Inter-Quartile Range 0 |
p-value: 0.048995% CI: [0, 5]Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9
The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 5 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9 | 0 Units on a scale | Inter-Quartile Range 0 |
| Delayed Pramipexole | Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9 | -0.5 Units on a scale | Inter-Quartile Range -0.5 |
p-value: 0.028295% CI: [0, 5]Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15 | 0.2 Units on a scale | Standard Error 0.5 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15 | -0.1 Units on a scale | Standard Error 0.5 |
p-value: 0.739595% CI: [-1.1, 1.5]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time frame: Baseline and Month 3
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3 | -2.1 Units on a scale | Standard Error 0.4 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3 | -0.3 Units on a scale | Standard Error 0.4 |
p-value: 0.000295% CI: [-2.7, -0.9]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time frame: Baseline and Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6 | -1.6 Units on a scale | Standard Error 0.4 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6 | 1.3 Units on a scale | Standard Error 0.4 |
p-value: <0.000195% CI: [-4, -1.8]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9
The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9 | -0.6 Units on a scale | Standard Error 0.5 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9 | 2.7 Units on a scale | Standard Error 0.5 |
p-value: <0.000195% CI: [-4.5, -2.2]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15 | 0.6 Units on a scale | Standard Error 0.2 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15 | 0.6 Units on a scale | Standard Error 0.2 |
p-value: 0.979295% CI: [-0.6, 0.6]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time frame: Baseline and Month 3
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3 | -0.7 Units on a scale | Standard Error 0.2 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3 | 0.3 Units on a scale | Standard Error 0.2 |
p-value: <0.000195% CI: [-1.5, -0.6]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time frame: Baseline and Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6 | 0.1 Units on a scale | Standard Error 0.2 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6 | 1.2 Units on a scale | Standard Error 0.2 |
p-value: <0.000195% CI: [-1.6, -0.6]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9
The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9 | 0.4 Units on a scale | Standard Error 0.2 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9 | 1.5 Units on a scale | Standard Error 0.2 |
p-value: 0.000195% CI: [-1.7, -0.5]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15 | -0.2 Units on a scale | Standard Error 0.1 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15 | -0.1 Units on a scale | Standard Error 0.1 |
p-value: 0.160795% CI: [-0.4, 0.1]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time frame: Baseline and Month 3
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3 | -0.2 Units on a scale | Standard Error 0.1 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3 | -0.1 Units on a scale | Standard Error 0.1 |
p-value: 0.438195% CI: [-0.3, 0.1]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time frame: Baseline and Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6 | -0.3 Units on a scale | Standard Error 0.1 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6 | 0.1 Units on a scale | Standard Error 0.1 |
p-value: 0.000795% CI: [-0.6, -0.2]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9
The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9 | -0.2 Units on a scale | Standard Error 0.1 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9 | 0.1 Units on a scale | Standard Error 0.1 |
p-value: 0.017395% CI: [-0.5, -0.1]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15 | 0.8 Units on a scale | Standard Error 0.7 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15 | 0.6 Units on a scale | Standard Error 0.7 |
p-value: 0.815595% CI: [-1.5, 1.9]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time frame: Baseline and Month 3
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3 | -2.8 Units on a scale | Standard Error 0.5 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3 | 0.0 Units on a scale | Standard Error 0.5 |
p-value: <0.000195% CI: [-3.9, -1.7]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time frame: Baseline and Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6 | -1.5 Units on a scale | Standard Error 0.6 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6 | 2.5 Units on a scale | Standard Error 0.6 |
p-value: <0.000195% CI: [-5.4, -2.6]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9
The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9 | -0.3 Units on a scale | Standard Error 0.6 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9 | 4.2 Units on a scale | Standard Error 0.6 |
p-value: <0.000195% CI: [-6, -3]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15 | 0.6 Units on a scale | Standard Error 0.7 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15 | 0.5 Units on a scale | Standard Error 0.7 |
p-value: 0.956895% CI: [-1.7, 1.8]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time frame: Baseline and Month 3
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3 | -2.9 Units on a scale | Standard Error 0.5 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3 | -0.1 Units on a scale | Standard Error 0.5 |
p-value: <0.000195% CI: [-4.1, -1.7]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time frame: Baseline and Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6 | -1.8 Units on a scale | Standard Error 0.6 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6 | 2.6 Units on a scale | Standard Error 0.6 |
p-value: <0.000195% CI: [-5.8, -3]ANCOVA
Secondary
Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9
The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 1 patient from the FAS2 was excluded due to insufficient efficacy data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9 | -0.5 Units on a scale | Standard Error 0.6 |
| Delayed Pramipexole | Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9 | 4.3 Units on a scale | Standard Error 0.6 |
p-value: <0.000195% CI: [-6.3, -3.2]ANCOVA
Secondary
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Time frame: Baseline and Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15 | -0.4 Units on a scale | Inter-Quartile Range -0.4 |
| Delayed Pramipexole | Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15 | 0.3 Units on a scale | Inter-Quartile Range 0.3 |
p-value: 0.214995% CI: [-1.823, 0.677]Wilcoxon (Mann-Whitney)
Secondary
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9
The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)
Time frame: Baseline and Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 3 patients from the FAS2 were excluded due to insufficient efficacy data.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9 | -0.5 Units on a scale | Inter-Quartile Range -0.5 |
| Delayed Pramipexole | Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9 | 1.4 Units on a scale | Inter-Quartile Range 1.4 |
p-value: 0.000195% CI: [-3.125, -0.938]Wilcoxon (Mann-Whitney)
Secondary
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes
Time frame: Baseline and Month 15
Population: Gamma Glutamyltranspeptidase (GGT-N) was 214 for Early PPX and 208 for Delayed PPX, Amylase-N was 214 for Early PPX and 209 for Delayed PPX
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes | GGT - increase | 0.5 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes | Amylase - increase | 1.4 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes | GGT - increase | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes | Amylase - increase | 0 percentage of participants |
Secondary
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes
Time frame: Baseline and Month 15
Population: Treated set: Haematocrit and mean corpuscular volume (MCV-N) was 211 for Early PPX and 209 for Delayed PPX, Haemoglobin-N was 213 for Early PPX and 212 for Delayed PPX, Sodium-N was 211 for Early PPX and 209 for Delayed PPX, Calcium and Chloride-N was 214 for Early PPX and 209 for Delayed PPX, Phosphate-N was 201 for Early and Delayed PPX
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Haematocrit - decrease | 1.4 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Haemoglobin - decrease | 2.3 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | MCV - increase | 0.5 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Sodium - decrease | 1.4 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Calcium - increase | 0 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Chloride - decrease | 0.9 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Phosphate - decrease | 1.0 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Phosphate - increase | 0.5 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Phosphate - increase | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Haematocrit - decrease | 1.0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Calcium - increase | 0.5 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Haemoglobin - decrease | 0.9 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Phosphate - decrease | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | MCV - increase | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Chloride - decrease | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes | Sodium - decrease | 0.5 percentage of participants |
Secondary
Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates
Time frame: Baseline and Month 15
Population: Glucose-N was 28 for Early PPX and 46 for Delayed PPX, Cholesterol and Triglyceride-N was 213 for Early PPX and 208 for Delayed PPX, Blood Urea Nitrogen-N was 214 for Early PPX and 209 for Delayed PPX, Creatinine-N was 200 for Early PPX and 202 for Delayed PPX, Uric Acid-N was 212 for Early PPX and 209 for Delayed PPX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Cholesterol - increase | 1.4 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Creatinine - increase | 0.5 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Glucose - increase | 3.6 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Triglyceride - increase | 1.4 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Blood Urea Nitrogen - increase | 0.9 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Uric acid - increase | 0.5 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Glucose - decrease | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Uric acid - increase | 0.5 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Glucose - decrease | 2.2 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Glucose - increase | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Cholesterol - increase | 2.9 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Blood Urea Nitrogen - increase | 0.5 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Creatinine - increase | 1.0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates | Triglyceride - increase | 0 percentage of participants |
Secondary
Clinically Significant Abnormalities in Vital Signs
Time frame: Baseline and Month 15
Population: Phase 1 Treated set for sinus bradycardia with N of 261 for Early PPX and 274 for Delayed PPX. Phase 2 Treated set for hypotension with N of 221 for Early PPX and 214 for Delayed PPX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Clinically Significant Abnormalities in Vital Signs | Sinus bradycardia | 0 percentage of participants |
| Early Pramipexole | Clinically Significant Abnormalities in Vital Signs | Hypotension | 0 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Vital Signs | Sinus bradycardia | 0.4 percentage of participants |
| Delayed Pramipexole | Clinically Significant Abnormalities in Vital Signs | Hypotension | 0.5 percentage of participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time frame: Month 1
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 | No compulsive buying | 145 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 | Compulsive buying | 1 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 | No compulsive buying | 133 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1 | Compulsive buying | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time frame: Month 12
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 | No compulsive buying | 141 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 | Compulsive buying | 2 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 | No compulsive buying | 128 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12 | Compulsive buying | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time frame: Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 | No compulsive buying | 143 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 | Compulsive buying | 2 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 | No compulsive buying | 132 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15 | Compulsive buying | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time frame: Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 | No compulsive buying | 144 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 | Compulsive buying | 2 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 | No compulsive buying | 134 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6 | Compulsive buying | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.
Time frame: Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 | No compulsive buying | 143 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 | Compulsive buying | 3 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 | No compulsive buying | 134 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9 | Compulsive buying | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time frame: Month 1
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 | No compulsive sexual behaviour | 146 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 | Compulsive sexual behaviour | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 | No compulsive sexual behaviour | 133 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1 | Compulsive sexual behaviour | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time frame: Month 12
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 | No compulsive sexual behaviour | 143 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 | Compulsive sexual behaviour | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 | No compulsive sexual behaviour | 126 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12 | Compulsive sexual behaviour | 2 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time frame: Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 | No compulsive sexual behaviour | 145 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 | Compulsive sexual behaviour | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 | No compulsive sexual behaviour | 131 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15 | Compulsive sexual behaviour | 1 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time frame: Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 | No compulsive sexual behaviour | 146 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 | Compulsive sexual behaviour | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 | No compulsive sexual behaviour | 134 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6 | Compulsive sexual behaviour | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.
Time frame: Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 | No compulsive sexual behaviour | 146 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 | Compulsive sexual behaviour | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 | No compulsive sexual behaviour | 134 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9 | Compulsive sexual behaviour | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time frame: Month 1
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 132 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 | No risk of gambling | 146 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 | Risk of gambling | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 | No risk of gambling | 133 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1 | Risk of gambling | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time frame: Month 12
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 140 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 | No risk of gambling | 143 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 | Risk of gambling | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 | No risk of gambling | 128 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12 | Risk of gambling | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time frame: Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 134 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 | No risk of gambling | 145 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 | Risk of gambling | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 | No risk of gambling | 132 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15 | Risk of gambling | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time frame: Month 6
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 | No risk of gambling | 146 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 | Risk of gambling | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 | No risk of gambling | 134 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6 | Risk of gambling | 0 Participants |
Secondary
Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9
The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.
Time frame: Month 9
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 131 patients from the FAS2 were excluded due to insufficient MMIDI data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 | No risk of gambling | 146 Participants |
| Early Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 | Risk of gambling | 0 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 | No risk of gambling | 134 Participants |
| Delayed Pramipexole | Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9 | Risk of gambling | 0 Participants |
Secondary
Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15
The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.
Time frame: Month 15
Population: The FAS2 was made up of all treated participants with a baseline and on-treatment blinded rater assessment of the UPDRS during Phase 2 of the trial. 27 patients from the FAS2 were excluded due to insufficient CGI-I data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Early Pramipexole | Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15 | 18 Participants |
| Delayed Pramipexole | Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15 | 21 Participants |
p-value: 0.511695% CI: [0.403, 1.573]Regression, Logistic
Secondary
Percentage Change From Baseline in the Striatum Uptake at Month 15
The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).
Time frame: Baseline and Month 15
Population: The substudy set was made up of all randomised patients with a baseline and end of treatment assessment of striatal uptake.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Early Pramipexole | Percentage Change From Baseline in the Striatum Uptake at Month 15 | -15.1 Percentage change | Standard Error 2.1 |
| Delayed Pramipexole | Percentage Change From Baseline in the Striatum Uptake at Month 15 | -14.6 Percentage change | Standard Error 2 |
p-value: 0.839795% CI: [-5.4, 4.4]ANCOVA