A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
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.
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 510 participants
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double dummy, blinded drug
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: November 6, 2018
Estimated Primary Completion Date: July 2020
Estimated Study Completion Date: July 2020
- Experimental: IPX203 ER CD-LD
- Active Comparator: IR CD-LD
|Date last updated at source||2019-09-18|
|Study start date||2018-11-06|
|Estimated primary completion date||2020-07-01|