NCT03877510

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 \[A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations\] may have the opportunity to enroll in this open-label study.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	IPX203	IPX203 extended release capsules

Timeline

• Start date: 2019-04-03
• Primary completion: 2022-03-21
• Completion: 2022-03-21
• First posted: 2019-03-15
• Last updated: 2023-07-13
• Results posted: 2023-06-06

Locations

98 sites across 8 countries: United States, Czechia, France, Germany, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study