CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 419 enrolled
Drug / intervention
IPX203drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03877510
NCT03877510Phase 3Completed
CompareCT.gov

An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations

Impax Laboratories, LLC·interventional·Posted Mar 15, 2019·Updated Jul 13, 2023

In Brief

A Phase 3 clinical trial evaluating IPX203 for Parkinson Disease. Completed, enrolled 419 participants across 98 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesCzechia, France, Germany, Italy, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMar 15, 2019
Enrollment StartApr 3, 2019
Primary CompletionMar 21, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.3 years ago

Interventions

IPX203drug

IPX203 extended release capsules