Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03877510 |
Recruitment Status :
Completed
First Posted : March 15, 2019
Last Update Posted : April 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Drug: IPX203 140 mg Drug: IPX203 210 mg Drug: IPX203 280 mg Drug: IPX203 350 mg | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 420 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations |
Actual Study Start Date : | April 3, 2019 |
Actual Primary Completion Date : | June 15, 2021 |
Actual Study Completion Date : | March 21, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Open Label IPX203
Subjects will receive IPX203 140 mg, IPX203 210 mg, IPX203 280 mg, or IPX203 350 mg for approximately 9 months. The dose and dosing frequency will be determined by the investigator.
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Drug: IPX203 140 mg
35 mg - 140 mg CD-LD extended release capsules
Other Name: IPX203 35-140 mg Drug: IPX203 210 mg 52.5 mg - 210 mg CD-LD extended release capsules
Other Name: IPX203 52.5-210 mg Drug: IPX203 280 mg 70 mg - 280 mg CD-LD extended release capsules
Other Name: IPX203 70-280mg Drug: IPX203 350 mg 87.5 mg - 350 mg CD-LD extended release capsules
Other Name: IPX203 87.5-350mg |
- Adverse Events [ Time Frame: Baseline through end of study up to 9 months ]Summary by system organ class and preferred terms of AEs
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Baseline ]
Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
Overall sum ranges from 0-260.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Month 3 ]
Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
Overall sum ranges from 0-260.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Month 6 ]
Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
Overall sum ranges from 0-260.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [ Time Frame: Month 9 ]
Measure of the MDS-UPDRS - sum total of 4 parts. Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator. Component IB is completed by the patient. Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
Overall sum ranges from 0-260.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [ Time Frame: Baseline ]
Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers.
Component IB is completed by the patient with or without help from the caregiver but independent of the investigator.
Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [ Time Frame: Month 3 ]
Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers.
Component IB is completed by the patient with or without help from the caregiver but independent of the investigator.
Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part1 [ Time Frame: Month 6 ]
Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers.
Component IB is completed by the patient with or without help from the caregiver but independent of the investigator.
Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [ Time Frame: Month 9 ]
Measure of the MDS-UPDRS - Part I: Non-Motor Aspects of Experiences of Daily Living (nM-EDL) has 2 components. Component IA contains a number of behaviors assessed by the investigator with all pertinent information from the patients and caregivers.
Component IB is completed by the patient with or without help from the caregiver but independent of the investigator.
Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Baseline ]Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Month 3 ]Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Month 6 ]Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [ Time Frame: Month 9 ]Measure of the MDS-UPDRS - Part II: Motor Aspects of Experiences of Daily Living (M-EDL) is a self-administered questionnaire Overall there are 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Baseline ]Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Month 3 ]Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Month 6 ]Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [ Time Frame: Month 9 ]Measure of the MDS-UPDRS - Part III: Motor Examination assesses the motor signs of PD; it is completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Baseline ]Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Month 3 ]Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Month 6 ]Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [ Time Frame: Month 9 ]Part IV: Motor Complications; completed by the rater. 6 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 24.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [ Time Frame: Baseline ]
Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) of Parts II and III [ Time Frame: Month 3 ]
Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [ Time Frame: Month 6 ]
Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
- Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [ Time Frame: Month 9 ]
Sum of MDS-UPDRS Parts II and III. Part II: Motor Aspects of Experiences of Daily Living (M-EDL) self-administered questionnaire. 13 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 52.
Part III: Motor Examination assesses the motor signs of PD; completed by the rater. 33 questions rated from 0 - normal to 4 severe. Total score ranges from 0 to 132 Total score ranges from 0 to 184.
- Treatment Satisfaction Assessment (TSA) [ Time Frame: Month 3 ]The TSA is a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied.
- Treatment Satisfaction Assessment (TSA) [ Time Frame: Month 6 ]The TSA is a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied.
- Treatment Satisfaction Assessment (TSA) [ Time Frame: Month 9 ]The TSA is a subject answered assessment rating treatment satisfaction on a scale of 1 to 7; 1 being least satisfied and 7 being most satisfied.
- Patient Global Impression of Severity (PGI-S) [ Time Frame: Baseline ]The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
- Patient Global Impression of Severity (PGI-S) [ Time Frame: Month 3 ]The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
- Patient Global Impression of Severity (PGI-S) [ Time Frame: Month 6 ]The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
- Patient Global Impression of Severity (PGI-S) [ Time Frame: Month 9 ]The PGI-S is a subject answered assessment rating Parkinson's disease severity on a scale of 1 to 7; 1 being normal not at all ill and 7 extremely severely ill.
- Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline ]The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
- Clinical Global Impression of Severity (CGI-S) [ Time Frame: Month 3 ]The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
- Clinical Global Impression of Severity (CGI-S) [ Time Frame: Month 6 ]The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
- Clinical Global Impression of Severity (CGI-S) [ Time Frame: Month 9 ]The CGI-S is a clinician scale rating the severity of the subject's illness on a scale of 1 to 7 with 1 being Normal, not at all ill and 7 being among the most extremely ill of subjects.
- 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Baseline ]The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
- 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Month 3 ]The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
- 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Month 6 ]The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
- 39-item Parkinson's disease questionnaire (PDQ-39) [ Time Frame: Month 9 ]The PDQ-39 is a self-reported 39 question Parkinson's disease Quality of Life Questionnaire with 5 choices ranging from "never" (least amount of difficulty) to Always (or cannot do at all; most difficult)
- Parkinson Anxiety Scale (PAS) [ Time Frame: Baseline ]
The PAS is a three part subject answered assessment. Totals for all three parts are summed.
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.
Possible overall best score: 0 Possible overall worst score: 48
- Parkinson Anxiety Scale (PAS) [ Time Frame: Month 3 ]
The PAS is a three part subject answered assessment. Totals for all three parts are summed.
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.
Possible overall best score: 0 Possible overall worst score: 48
- Parkinson Anxiety Scale (PAS) [ Time Frame: Month 6 ]
The PAS is a three part subject answered assessment. Totals for all three parts are summed.
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.
Possible overall best score: 0 Possible overall worst score: 48
- Parkinson Anxiety Scale (PAS) [ Time Frame: Month 9 ]
The PAS is a three part subject answered assessment. Totals for all three parts are summed.
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.
Possible overall best score: 0 Possible overall worst score: 48
- Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Baseline ]The NMSS is a 9 domain, 30 question scale rating symptom severity 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. Zero is the best score and 360 is the worst score.
- Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Month 3 ]The NMSS is a 9 domain, 30 question scale rating symptom severity 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. Zero is the best score and 360 is the worst score.
- Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Month 6 ]The NMSS is a 9 domain, 30 question scale rating symptom severity 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. Zero is the best score and 360 is the worst score.
- Non-motor symptom assessment scale for PD (NMSS) [ Time Frame: Month 9 ]The NMSS is a 9 domain, 30 question scale rating symptom severity 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. Zero is the best score and 360 is the worst score.
- Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Baseline ]The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
- Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Month 3 ]The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
- Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Month 6 ]The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.
- Parkinson's Disease Sleep Scale - 2 (PDSS-2) [ Time Frame: Month 9 ]The PDSS-2 is a 15 question subject response scale measuring the severity of sleep disturbance. Each question is rate as very often to never on a scale of 0-4. The best overall score is 0; the worst overall score is 60.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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 subjects 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.
- Subjects who, in the opinion of the clinical investigator, should not participate in the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877510

Study Director: | Impax Impax Study Director | Impax Laboratories, LLC |
Responsible Party: | Impax Laboratories, LLC |
ClinicalTrials.gov Identifier: | NCT03877510 |
Other Study ID Numbers: |
IPX203-B16-03 2018-002234-21 ( EudraCT Number ) |
First Posted: | March 15, 2019 Key Record Dates |
Last Update Posted: | April 7, 2022 |
Last Verified: | June 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
motor fluctuations IPX203 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |