Parkinson Disease
Conditions
Keywords
motor fluctuations, IPX203
Brief summary
The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.
Detailed description
This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 \[A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations\] may have the opportunity to enroll in this open-label study.
Interventions
DRUGIPX203
IPX203 extended release capsules
Sponsors
Impax Laboratories, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully completed Study IPX203-B16-02 * Able to provide written informed consent prior to the conduct of any study-specific procedures. * Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1). * Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.
Exclusion criteria
* Intends to use any doses of Rytary® or Duopa™ during this study. * Plans to use an investigational treatment other than IPX203 during the course of this study. * Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study. * Participants who, in the opinion of the clinical investigator, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET]) | An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was considered as treatment-emergent if the date of onset was on or after the date of the first open-label study drug administration in this Study IPX203-B16-03 and no later than 1 day after the last study drug dose in the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total | Baseline, Month 3, Month 6, and Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). |
| Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total | Baseline, Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). |
| Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I | Baseline, Month 3, Month 6, and Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD. |
| Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I | Baseline, Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD. |
| Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II | Baseline, Month 3, Month 6, and Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD. |
| Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II | Baseline, Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD. |
| Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III | Baseline, Month 3, Month 6, and Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD. |
| Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III | Baseline, Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD. |
| Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV | Baseline, Month 3, Month 6, and Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD. |
| Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV | Baseline, Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD. |
| Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III | Baseline, Month 3, Month 6, and Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD. |
| Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III | Baseline, Month 9/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD. |
| Patient Global Impression of Severity (PGI-S) | Baseline, Month 3, Month 6, and Month 9/ET | The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill. |
| Change From Baseline in Patient Global Impression of Severity (PGI-S) | Baseline, Month 9/ET | The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill. |
| Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Baseline, Month 3, Month 6, and Month 9/ET | The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill. |
| Clinical Global Impression of Severity (CGI-S) | Baseline, Month 3, Month 6, Month 9/ET | The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants. |
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) | Baseline, Month 9/ET | The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants. |
| Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Baseline, Month 3, Month 6, and Month 9/ET | The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants. |
| 39-item Parkinson's Disease Questionnaire (PDQ-39): Total | Baseline, Month 3, Month 6, and Month 9/ET | The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness. |
| Change From Baseline in PDQ-39: Total | Baseline, Month 9/ET | The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness. |
| Parkinson Anxiety Scale (PAS): Total | Baseline, Month 3, Month 6, and Month 9/ET | The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms. |
| Change From Baseline in Parkinson Anxiety Scale (PAS): Total | Baseline, Month 9/ET | The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms. |
| Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total | Baseline, Month 3, Month 6, and Month 9/ET | The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score. |
| Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total | Baseline, Month 9/ET | The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score. |
| Parkinson's Disease Sleep Scale-2 (PDSS-2) Total | Baseline, Month 3, Month 6, and Month 9/ET | The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60. |
| Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total | Baseline, Month 9/ET | The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60. |
| Treatment Satisfaction Assessment (TSA) | Month 3, Month 6 and Month 9/ET | The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied. |
| Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) | Month 3, Month 6, and Month 9/ET | The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied. |
Countries
Czechia, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants who successfully completed Study IPX203-B16-02 (NCT03670953) had the opportunity to enroll in the 9-month, open-label safety extension IPX203-B16-03 (NCT03877510) study. A total of 419 participants were enrolled.
Pre-assignment details
Participants with Parkinson's Disease (PD) who were treated with stable regimens of carbidopa - levodopa (CD - LD) and had successfully completed previous IPX203-B16-02 study had the opportunity to enroll in this open-label study.
Participants by arm
| Arm | Count |
|---|---|
| Open Label IPX203 All participants received oral administration of extended-release capsules IPX203 dosing regimen that was determined at the end of the IPX203 dose conversion period of Study IPX203-B16-02 (NCT03670953) for nine months of open-label therapy. The dose and dosing frequency was determined by the investigator to achieve the optimal balance of efficacy and safety. | 419 |
| Total | 419 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 20 |
| Overall Study | Death | 6 |
| Overall Study | Lack of Efficacy | 14 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Miscellaneous | 1 |
| Overall Study | Non-compliance with study drug | 2 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | Open Label IPX203 |
|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 8.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 369 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 406 Participants |
| Sex: Female, Male Female | 140 Participants |
| Sex: Female, Male Male | 279 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 419 |
| other Total, other adverse events | 99 / 419 |
| serious Total, serious adverse events | 42 / 419 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was considered as treatment-emergent if the date of onset was on or after the date of the first open-label study drug administration in this Study IPX203-B16-03 and no later than 1 day after the last study drug dose in the study.
Time frame: From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET])
Population: The Safety Analysis Set (SAS) included all participants who were treated with the open-label study drug in the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open Label IPX203 | Number of Participants With Treatment-Emergent Adverse Events | 221 Participants |
Secondary
39-item Parkinson's Disease Questionnaire (PDQ-39): Total
The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | 39-item Parkinson's Disease Questionnaire (PDQ-39): Total | Baseline | 41.7 score on a scale | Standard Deviation 27.71 |
| Open Label IPX203 | 39-item Parkinson's Disease Questionnaire (PDQ-39): Total | Month 3 | 42.7 score on a scale | Standard Deviation 27.73 |
| Open Label IPX203 | 39-item Parkinson's Disease Questionnaire (PDQ-39): Total | Month 6 | 42.8 score on a scale | Standard Deviation 28.15 |
| Open Label IPX203 | 39-item Parkinson's Disease Questionnaire (PDQ-39): Total | Month 9/ET | 45.1 score on a scale | Standard Deviation 29.45 |
Secondary
Change From Baseline in Clinical Global Impression of Severity (CGI-S)
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Clinical Global Impression of Severity (CGI-S) | 0.0 score on a scale | Standard Deviation 0.81 |
Secondary
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I | 1.2 score on a scale | Standard Deviation 4.56 |
Secondary
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II | 0.9 score on a scale | Standard Deviation 4.81 |
Secondary
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III | 0.6 score on a scale | Standard Deviation 11.29 |
Secondary
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV | 0.0 score on a scale | Standard Deviation 2.64 |
Secondary
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III | 1.5 score on a scale | Standard Deviation 13.66 |
Secondary
Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260).
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total | 2.7 score on a scale | Standard Deviation 16.44 |
Secondary
Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total | 3.8 score on a scale | Standard Deviation 22.33 |
Secondary
Change From Baseline in Parkinson Anxiety Scale (PAS): Total
The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Parkinson Anxiety Scale (PAS): Total | 0.9 score on a scale | Standard Deviation 6.41 |
Secondary
Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total
The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total | -0.1 score on a scale | Standard Deviation 8.92 |
Secondary
Change From Baseline in Patient Global Impression of Severity (PGI-S)
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in Patient Global Impression of Severity (PGI-S) | 0.0 score on a scale | Standard Deviation 1.07 |
Secondary
Change From Baseline in PDQ-39: Total
The PDQ-39 is a self-reported outcome of 39 questions relating to 8 domains: mobility (Questions 1-10), activities of daily living (ADL) (Questions 11-16), emotional well-being (Questions 17-22), stigma (Questions 23-26), social support (Questions 27-29), cognition (Questions 30-33), communication (Questions 34-36) and bodily discomfort (Questions 37-39). Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness.
Time frame: Baseline, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with Baseline and Month 9/ET data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open Label IPX203 | Change From Baseline in PDQ-39: Total | 4.4 score on a scale | Standard Deviation 18.65 |
Secondary
Clinical Global Impression of Severity (CGI-S)
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Time frame: Baseline, Month 3, Month 6, Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Clinical Global Impression of Severity (CGI-S) | Month 9/ET | 3.8 score on a scale | Standard Deviation 0.97 |
| Open Label IPX203 | Clinical Global Impression of Severity (CGI-S) | Baseline | 3.8 score on a scale | Standard Deviation 0.87 |
| Open Label IPX203 | Clinical Global Impression of Severity (CGI-S) | Month 3 | 3.8 score on a scale | Standard Deviation 0.92 |
| Open Label IPX203 | Clinical Global Impression of Severity (CGI-S) | Month 6 | 3.7 score on a scale | Standard Deviation 0.87 |
Secondary
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part I score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I | Month 6 | 10.7 score on a scale | Standard Deviation 6.21 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I | Baseline | 9.9 score on a scale | Standard Deviation 6.27 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I | Month 3 | 10.6 score on a scale | Standard Deviation 6.43 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I | Month 9/ET | 11.0 score on a scale | Standard Deviation 6.72 |
Secondary
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part II score ranges from 0 to 52. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II | Month 6 | 12.8 score on a scale | Standard Deviation 7.69 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II | Month 9/ET | 13.6 score on a scale | Standard Deviation 8.11 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II | Baseline | 12.8 score on a scale | Standard Deviation 7.83 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II | Month 3 | 13.0 score on a scale | Standard Deviation 7.96 |
Secondary
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part III score ranges from 0 to 132. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III | Baseline | 27.5 score on a scale | Standard Deviation 17.23 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III | Month 3 | 26.8 score on a scale | Standard Deviation 17.9 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III | Month 6 | 26.6 score on a scale | Standard Deviation 17.5 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III | Month 9/ET | 27.8 score on a scale | Standard Deviation 16.79 |
Secondary
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). Part IV score ranges from 0 to 24. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV | Baseline | 6.6 score on a scale | Standard Deviation 2.96 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV | Month 3 | 6.0 score on a scale | Standard Deviation 3.15 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV | Month 6 | 6.0 score on a scale | Standard Deviation 3.08 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV | Month 9/ET | 6.6 score on a scale | Standard Deviation 3.34 |
Secondary
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260). The scale range for Part II+III score is 0-184. A higher score indicated more severe symptoms of PD.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III | Month 9/ET | 41.5 score on a scale | Standard Deviation 22.96 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III | Baseline | 40.3 score on a scale | Standard Deviation 23.09 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III | Month 3 | 39.8 score on a scale | Standard Deviation 24.15 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III | Month 6 | 39.4 score on a scale | Standard Deviation 23.24 |
Secondary
Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 33 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-260).
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: The Intent-to-Treat (ITT) Analysis Set included all participants who were treated with the open-label study drug in the study and had at least one post-baseline clinical utility assessment. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total | Month 9/ET | 59.0 score on a scale | Standard Deviation 29.11 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total | Baseline | 56.7 score on a scale | Standard Deviation 28.64 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total | Month 3 | 56.5 score on a scale | Standard Deviation 30.14 |
| Open Label IPX203 | Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total | Month 6 | 56.0 score on a scale | Standard Deviation 28.92 |
Secondary
Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
The NMSS assesses non-motor symptoms in Parkinson's Disease. It consists of 30 questions grouped into 9 domains: cardiovascular, sleep/fatigue, mood/cognition, perceptual problems/hallucinations, attention/memory, gastro-intestinal tract, urinary, sexual function, and miscellaneous. Severity symptoms are rated on a scale of 0-3 with 3 being most severe; and frequency on a scale of 1-4 with 4 being most frequent. Each question is answered with a severity and frequency rating which are then multiplied. The sum of the products gives the total score which ranges from 0 to 360 with a lower score more desirable than a higher score.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total | Baseline | 32.0 score on a scale | Standard Deviation 28.95 |
| Open Label IPX203 | Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total | Month 3 | 32.5 score on a scale | Standard Deviation 28.49 |
| Open Label IPX203 | Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total | Month 6 | 33.4 score on a scale | Standard Deviation 29.19 |
| Open Label IPX203 | Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total | Month 9/ET | 35.3 score on a scale | Standard Deviation 30.08 |
Secondary
Parkinson Anxiety Scale (PAS): Total
The PAS is a three part participant answered assessment. Part 1 has 5 questions measuring persistent anxiety. Each question ranges from 0 - not at all, or never to 4 severe, or nearly always. Best score is 0; worst score is 20. Part 2 has 4 questions measuring episodic anxiety. Each question ranges from 0 - never to 4 - nearly always. Best score is 0; worst score is 16. Part 3 has 3 questions measuring avoidance behavior. Each question ranges from 0, never to 4 nearly always. Best score is 0; worst score is 12. Totals for all three parts are summed and ranges from 0 to 48, higher scores are associated with the more severe symptoms.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Parkinson Anxiety Scale (PAS): Total | Baseline | 10.4 score on a scale | Standard Deviation 8.18 |
| Open Label IPX203 | Parkinson Anxiety Scale (PAS): Total | Month 3 | 10.3 score on a scale | Standard Deviation 8.2 |
| Open Label IPX203 | Parkinson Anxiety Scale (PAS): Total | Month 6 | 10.3 score on a scale | Standard Deviation 7.67 |
| Open Label IPX203 | Parkinson Anxiety Scale (PAS): Total | Month 9/ET | 11.1 score on a scale | Standard Deviation 8.57 |
Secondary
Parkinson's Disease Sleep Scale-2 (PDSS-2) Total
The PDSS-2 is a 15 question participant response scale measuring the severity of sleep disturbance. Three domains are defined: disturbed sleep (Questions 1-3, 8, 14), motor symptoms at night (Questions 4-6, 12, 13), PD symptoms at night (Questions 7, 9-11, 15). Each question is rated as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Parkinson's Disease Sleep Scale-2 (PDSS-2) Total | Baseline | 16.6 score on a scale | Standard Deviation 9.72 |
| Open Label IPX203 | Parkinson's Disease Sleep Scale-2 (PDSS-2) Total | Month 3 | 15.8 score on a scale | Standard Deviation 9.16 |
| Open Label IPX203 | Parkinson's Disease Sleep Scale-2 (PDSS-2) Total | Month 6 | 16.1 score on a scale | Standard Deviation 9.29 |
| Open Label IPX203 | Parkinson's Disease Sleep Scale-2 (PDSS-2) Total | Month 9/ET | 16.2 score on a scale | Standard Deviation 9.28 |
Secondary
Patient Global Impression of Severity (PGI-S)
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population. Overall Number of Participants Analyzed included participants with available data at any timepoint. Number Analyzed included participants with available data at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Patient Global Impression of Severity (PGI-S) | Month 9/ET | 3.8 score on a scale | Standard Deviation 1.12 |
| Open Label IPX203 | Patient Global Impression of Severity (PGI-S) | Baseline | 3.7 score on a scale | Standard Deviation 1.02 |
| Open Label IPX203 | Patient Global Impression of Severity (PGI-S) | Month 3 | 3.8 score on a scale | Standard Deviation 1 |
| Open Label IPX203 | Patient Global Impression of Severity (PGI-S) | Month 6 | 3.7 score on a scale | Standard Deviation 0.99 |
Secondary
Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5
The CGI-S is a clinician scale rating the severity of the participant's illness on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Among the most extremely ill of participants.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Baseline CGI-S ≥ 4 | 66.7 Percentage of participants |
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Baseline CGI-S ≥ 5 | 19.6 Percentage of participants |
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Month 3 CGI-S ≥ 4 | 64.8 Percentage of participants |
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Month 3 CGI-S ≥ 5 | 18.3 Percentage of participants |
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Month 6 CGI-S ≥ 4 | 61.2 Percentage of participants |
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Month 6 CGI-S ≥ 5 | 14.0 Percentage of participants |
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Month 9/ET CGI-S ≥ 4 | 65.3 Percentage of participants |
| Open Label IPX203 | Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5 | Month 9/ET CGI-S ≥ 5 | 17.6 Percentage of participants |
Secondary
Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5
The PGI-S is a participant answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1-Normal, not at all ill, 2-Borderline ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, 7-Extremely severely ill.
Time frame: Baseline, Month 3, Month 6, and Month 9/ET
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Month 6 PGI-S ≥ 4 | 62.5 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Month 6 PGI-S ≥ 5 | 20.7 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Month 9/ET PGI-S ≥ 4 | 65.4 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Baseline PGI-S ≥ 4 | 64.5 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Baseline PGI-S ≥ 5 | 20.3 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Month 3 PGI-S ≥ 4 | 66.7 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Month 3 PGI-S ≥ 5 | 20.0 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5 | Month 9/ET PGI-S ≥ 5 | 22.6 Percentage of Participants |
Secondary
Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral)
The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.
Time frame: Month 3, Month 6, and Month 9/ET
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Open Label IPX203 | Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) | Month 3: Percentage of TSA Scores 1-4 (Dissatisfied or Neutral) | 19.6 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) | Month 3: Percentage of TSA Scores 5-7 (Satisfied) | 80.4 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) | Month 6: Percentage of TSA Scores 1-4 (Dissatisfied or Neutral) | 15.6 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) | Month 6: Percentage of TSA Scores 5-7 (Satisfied) | 84.4 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) | Month 9/ET: Percentage of TSA Scores 1-4 (Dissatisfied or Neutral) | 23.7 Percentage of Participants |
| Open Label IPX203 | Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral) | Month 9/ET: Percentage of TSA Scores 5-7 (Satisfied) | 76.3 Percentage of Participants |
Secondary
Treatment Satisfaction Assessment (TSA)
The TSA is a participant answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 = Very much dissatisfied being least satisfied and 7 = Very much satisfied.
Time frame: Month 3, Month 6 and Month 9/ET
Population: ITT population with available data was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label IPX203 | Treatment Satisfaction Assessment (TSA) | Month 3 | 5.2 score on a scale | Standard Deviation 1.25 |
| Open Label IPX203 | Treatment Satisfaction Assessment (TSA) | Month 6 | 5.4 score on a scale | Standard Deviation 1.19 |
| Open Label IPX203 | Treatment Satisfaction Assessment (TSA) | Month 9/ET | 5.2 score on a scale | Standard Deviation 1.39 |