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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.

Status
Open and enrolling subjects.
Location
Phoenix, Arizona
Age Range
  • 40+
Total Participants
510
Primary Sponsor
Impax Laboratories, LLC