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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 April 2022
Main ID:	NCT03877510
Date of registration:	12/03/2019
Prospective Registration:	Yes
Primary sponsor:	Impax Laboratories, LLC
Public title:	Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations
Scientific title:	An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
Date of first enrolment:	April 3, 2019
Target sample size:	420
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03877510
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 3

Countries of recruitment
Czechia	France	Germany	Italy	Poland	Spain	United Kingdom	United States

Contacts

Name:	Impax Impax Study Director
Address:
Telephone:
Email:
Affiliation:	Impax Laboratories, LLC

Key inclusion & exclusion 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.

Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: IPX203 280 mg

Drug: IPX203 140 mg

Drug: IPX203 350 mg

Drug: IPX203 210 mg

Primary Outcome(s)

Adverse Events [Time Frame: Baseline through end of study up to 9 months]

Secondary Outcome(s)

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [Time Frame: Baseline]

39-item Parkinson's disease questionnaire (PDQ-39) [Time Frame: Baseline]

39-item Parkinson's disease questionnaire (PDQ-39) [Time Frame: Month 9]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [Time Frame: Baseline]

Clinical Global Impression of Severity (CGI-S) [Time Frame: Baseline]

Clinical Global Impression of Severity (CGI-S) [Time Frame: Month 9]

Non-motor symptom assessment scale for PD (NMSS) [Time Frame: Baseline]

Parkinson's Disease Sleep Scale - 2 (PDSS-2) [Time Frame: Month 6]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [Time Frame: Month 3]

39-item Parkinson's disease questionnaire (PDQ-39) [Time Frame: Month 3]

Clinical Global Impression of Severity (CGI-S) [Time Frame: Month 3]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part1 [Time Frame: Month 6]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [Time Frame: Baseline]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 [Time Frame: Month 9]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [Time Frame: Month 6]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [Time Frame: Month 6]

Non-motor symptom assessment scale for PD (NMSS) [Time Frame: Month 3]

Non-motor symptom assessment scale for PD (NMSS) [Time Frame: Month 9]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [Time Frame: Month 9]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [Time Frame: Month 9]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [Time Frame: Month 9]

Parkinson's Disease Sleep Scale - 2 (PDSS-2) [Time Frame: Baseline]

Treatment Satisfaction Assessment (TSA) [Time Frame: Month 3]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [Time Frame: Month 3]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [Time Frame: Baseline]

Parkinson Anxiety Scale (PAS) [Time Frame: Month 3]

Parkinson's Disease Sleep Scale - 2 (PDSS-2) [Time Frame: Month 9]

Patient Global Impression of Severity (PGI-S) [Time Frame: Month 6]

39-item Parkinson's disease questionnaire (PDQ-39) [Time Frame: Month 6]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) of Parts II and III [Time Frame: Month 3]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [Time Frame: Baseline]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [Time Frame: Month 3]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [Time Frame: Baseline]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [Time Frame: Month 3]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III [Time Frame: Month 9]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total [Time Frame: Month 3]

Non-motor symptom assessment scale for PD (NMSS) [Time Frame: Month 6]

Parkinson Anxiety Scale (PAS) [Time Frame: Baseline]

Patient Global Impression of Severity (PGI-S) [Time Frame: Baseline]

Clinical Global Impression of Severity (CGI-S) [Time Frame: Month 6]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [Time Frame: Month 6]

Parkinson Anxiety Scale (PAS) [Time Frame: Month 6]

Patient Global Impression of Severity (PGI-S) [Time Frame: Month 3]

Patient Global Impression of Severity (PGI-S) [Time Frame: Month 9]

Treatment Satisfaction Assessment (TSA) [Time Frame: Month 6]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 [Time Frame: Month 6]

Treatment Satisfaction Assessment (TSA) [Time Frame: Month 9]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 [Time Frame: Month 6]

Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 [Time Frame: Month 9]

Parkinson Anxiety Scale (PAS) [Time Frame: Month 9]

Parkinson's Disease Sleep Scale - 2 (PDSS-2) [Time Frame: Month 3]

Secondary ID(s)

IPX203-B16-03

2018-002234-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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