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Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations

NCT03877510 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2023-07-13

Study results available
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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.

Conditions

  • Parkinson Disease

Interventions

DRUG

IPX203

IPX203 extended release capsules

Sponsors & Collaborators

  • Impax Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Impax Impax Study Director · Impax Laboratories, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2022-03-21
Completion
2022-03-21
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877510 on ClinicalTrials.gov