NCT03670953

A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 630 (actual)
• Sponsor: Impax Laboratories, LLC · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.

Detailed description

This was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study consisted of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with participants randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo).

Conditions

• Parkinson's Disease (Disorder)

Interventions

Type	Name	Description
DRUG	IR CD-LD	Active comparator - IR CD-LD
DRUG	IPX203 ER CD-LD	Investigational formulation - ER CD-LD
OTHER	Placebo Matching IPX203	Double dummy placebo capsules
OTHER	Placebo Matching IR CD-LD	Double dummy placebo tablets

Timeline

• Start date: 2018-11-06
• Primary completion: 2021-06-15
• Completion: 2021-06-15
• First posted: 2018-09-14
• Last updated: 2023-02-09
• Results posted: 2023-02-09

Locations

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

Regulatory

• FDA-regulated drug study