Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations

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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Impax Laboratories, LLC

Study Description

Brief Summary:

The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of subjects with advanced Parkinson's disease (PD) who have motor fluctuations.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Drug: IPX203 140 mg Drug: IPX203 210 mg Drug: IPX203 280 mg Drug: IPX203 350 mg	Phase 3

Detailed Description:

This is a 9-month, multicenter open-label safety extension study. Subjects who have successfully completed Study IPX203-B16-02 [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.

Study Design

Layout table for study information

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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Arms and Interventions

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.	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

Outcome Measures

Primary Outcome Measures :

Adverse Events [ Time Frame: Baseline through end of study up to 9 months ]
Summary by system organ class and preferred terms of AEs

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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.

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Ages Eligible for Study:	40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

Show 98 study locations

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United States, Arizona
Xenoscience, Inc (102)
Phoenix, Arizona, United States, 85004
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)
Phoenix, Arizona, United States, 85013
United States, Arkansas
Clinical Trials, Inc (113)
Little Rock, Arkansas, United States, 72205
University of Arkansas for Medical Sciences (117)
Little Rock, Arkansas, United States, 72205
United States, California
Keek School of Medicine of USC/ University of Southern California (106)
Los Angeles, California, United States, 90033
Hoag Memorial Hospital Presbyterian (134)
Newport Beach, California, United States, 92663
SC3 Research-Pasadena (148)
Pasadena, California, United States, 91105
SC3 Research-Reseda (146)
Reseda, California, United States, 91335
United States, Colorado
University of Colorado Hospital Anschutz Outpatient Pavilion (120)
Aurora, Colorado, United States, 80045
Rocky Mountain Movement Disorders (116)
Englewood, Colorado, United States, 80113
United States, Delaware
ChristianaCare Neurology Specialists (153)
Newark, Delaware, United States, 19713
United States, Florida
JEM Research Institute (136)
Atlantis, Florida, United States, 33462
Visionary Investigators Network (168)
Aventura, Florida, United States, 33180
UHealth at Boca Raton (152)
Boca Raton, Florida, United States, 33431
Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
Boca Raton, Florida, United States, 33486
Infinity Clinical Research LLC (104)
Hollywood, Florida, United States, 33024
University of Florida Health Science Center (129)
Jacksonville, Florida, United States, 32209
Neurology Associates, P.A. (125)
Maitland, Florida, United States, 32751
University of Miami (149)
Miami, Florida, United States, 33136
Medical Professional Clinical Research Center, Inc. (163)
Miami, Florida, United States, 33165
Parkinson's Disease Treatment Center of Southwest Florida (131)
Port Charlotte, Florida, United States, 33980
Infinity Clinical Research, LLC (105)
Sunrise, Florida, United States, 33351
University of South Florida (114)
Tampa, Florida, United States, 33615
Premiere Research Institute at Palm Beach Neurology (174)
West Palm Beach, Florida, United States, 33407
Charter Research (166)
Winter Park, Florida, United States, 32792
United States, Georgia
Emory Brain Health Center (110)
Atlanta, Georgia, United States, 30329
NeuroStudies.net, LLC (155)
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern Medical Group Neurology Clinic (145)
Chicago, Illinois, United States, 60611
Central DuPage Hospital (151)
Winfield, Illinois, United States, 60190
United States, Indiana
Indiana University Health Neuroscience Center(164)
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center (118)
Kansas City, Kansas, United States, 66160
United States, Michigan
Quest Research Institute (103)
Farmington Hills, Michigan, United States, 48334
Henry Ford West Bloomfield Hospital(100)
West Bloomfield, Michigan, United States, 48322
United States, Missouri
Washington University (109)
Saint Louis, Missouri, United States, 63110
United States, Nevada
Roseman Medical Research Institute / Roseman Medical Group (154)
Las Vegas, Nevada, United States, 17601
Cleveland Clinic Lou Ruvo Center for Brain Health (142)
Las Vegas, Nevada, United States, 89106
United States, New York
Albany Medical College (139)
Albany, New York, United States, 12208
United States, Ohio
Ucgni (133)
Cincinnati, Ohio, United States, 45219
University Hospitals Cleveland Medical Center (123)
Cleveland, Ohio, United States, 44106
Cleveland Clinic(144)
Cleveland, Ohio, United States, 44195
University of Toledo, Gardner-McMaster Parkinson Center (122)
Toledo, Ohio, United States, 43614
United States, Oklahoma
The Movement Disorder Clinic of Oklahoma (115)
Tulsa, Oklahoma, United States, 74136
United States, Tennessee
The Vanderbilt Clinic (158)
Nashville, Tennessee, United States, 37232
United States, Texas
Neurology Consultants of Dallas, PA (108)
Dallas, Texas, United States, 75251
University of Texas Southwestern Medical Center (143)
Dallas, Texas, United States, 75390-9184
Houston Methodist Neurological Institute/Movement Disorders Clinic (135)
Houston, Texas, United States, 77030
United States, Virginia
Inova Neurology- Fairfax (147)
Fairfax, Virginia, United States, 17601
VCU Health- Neuroscience Orthopaedic and Wellness Center(124)
Henrico, Virginia, United States, 23233
United States, Washington
Booth Gardner Parkinson's Care Center (112)
Kirkland, Washington, United States, 98034
Inland Northwest Research (119)
Spokane, Washington, United States, 99202
Czechia
Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)
Brno, Czechia, 65691
NEUROHK. s.r.o. (701)
Choceň, Czechia, 56501
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)
Pardubice, Czechia, 53203
CLINTRIAL s.r.o. (703)
Praha 10, Czechia, 10000
AXON Clinical. s.r.o. (700)
Praha 5, Czechia, 15000
Neurologicka ordinace FORBELI s.r.o. (706)
Praha 6, Czechia, 16000
France
CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)
Clermont-Ferrand Cedex 1, France, 63003
CHU de Montpellier, Hopital Gui de Chauliac (405)
Montpellier Cedex 5, France, 34295
Centre Hospitalier Universitaire de Nice (400)
Nice, France, 06002
Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)
Toulouse Cedex 9, France, 31059
Germany
Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)
Beelitz-Heilstätten, Beelitz, Germany, 14547
St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)
Bochum, Gudrunstabe 56, Germany, 44791
Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)
München, Ismaningerstrabe, Germany, 81675
Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)
Berlin, Germany, 12163
Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)
Haag In Oberbayern, Germany, 83527
Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)
Westerstede, Germany, 26655
Italy
Centro Ricerca Parkinson San Raffaele Cassino (601)
Cassino, Frosinone, Italy, 03043
Università G. D'annunzio CeSi Met (604)
Chieti, Italy/Chieti/Abbruzzo, Italy, 66100
Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)
Pavia, Italy/Pavia/Lombardia, Italy, 27100
Azienda Ospedaliero-Universitaria Pisana (602)
Pisa, Italy/Pisa/Toscana, Italy, 56126
IRCCS San Raffaele Pi sana (600)
Roma, Italy/Roma/Lazio, Italy, 00163
Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)
Roma, Italy/Roma/Lazio, Italy, 00189
University of Rome Tor Vergata/Hospital Tor Vergata (605)
Roma, Lazio, Italy, 00133
Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)
Catania, Sicily, Italy, 95123
Poland
Centrum Medyczne Neuromed (803)
Bydgoszcz, Poland, 85163
Centrum Medyczne Linden (805)
Kraków, Poland, 30721
Krakowska Akademia Neurologii Sp. Zo.o.(802)
Kraków, Poland, 31-505
NZOZ Neuromed M. i M. Nastaj Sp.p. (800)
Lublin, Poland, 20-064
NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
Poznań, Poland, 61853
Neuro-Care Sp. z o.o. sp. k. (804)
Siemianowice Śląskie, Poland, 41100
Centrum Medycme NeuroProtect (806)
Warszawa, Poland, 01-684
Spain
Hospital General Universitario de Elche (509)
Elche, Alicante, Spain, 03203
Hospital Universitari General de Catalunya (504)
Sant Cugat Del Vallès, Barcelona, Spain, 08195
Hospital Universitari Mutua Terrassa (506)
Terrassa, Barcelona, Spain, 08222
Policlinica Gipuzkoa, S.A (511)
Donostia San Sebastian, Gipuzkoa, Spain, 20014
Clinica Universidad de Navarra (512)
Pamplona, Navarra, Spain, 31008
Hospital Universitario Quiron Dexeus (501)
Barcelona, Spain, 08028
Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
Barcelona, Spain, 08035
Hospital Universitario Vall d'Hebron (505)
Barcelona, Spain, 08035
Hospital de Ia Santa Creu i Sant Pau (502)
Barcelona, Spain, 08041
Hospital Universitario de Ia Princesa (508)
Madrid, Spain, 28006
Hospital Universitario Ramon y Cajal (500)
Madrid, Spain, 28034
Hospital Universitario Infanta Sofia(513)
Madrid, Spain, 28703
Hospital Universitario Virgen del Rocio (503)
Sevilla, Spain, 41013
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)
Valencia, Spain, 46026
United Kingdom
Re:Cognition Health Ltd (205)
Plymouth, Devon, United Kingdom, PL68BT
Imperial College Healthcare NI-lS Trust (200)
London, United Kingdom, W68RF
Re:Cognition Health Ltd (202)
London, United Kingdom, WlG9JF

Sponsors and Collaborators

Impax Laboratories, LLC

Investigators

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Study Director:	Impax Impax Study Director	Impax Laboratories, LLC

More Information

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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

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Impax Laboratories, LLC:


motor fluctuations IPX203

Additional relevant MeSH terms:

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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases	Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases

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