Last updated on November 2019

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


Brief description of study

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 subjects with Parkinson's disease (PD) who have motor fluctuations.

Detailed Study Description

This is a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study will consist 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 subjects 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). Approximately 510 subjects will be enrolled to randomize 420 subjects.

Clinical Study Identifier: NCT03670953

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