ClinicalTrials.gov Identifier: NCT03670953
IPX203-B16-02: A Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study to evaluate the safety and efficacy of the investigational product IPX203 (carbidopa and levodopa or “CD-LD”) extended-release (ER) capsules in comparison to immediate release (IR) CD-LD in Parkinson's disease (PD) subjects who have motor fluctuations.
What does participation involve?
The study includes seven visits to the study center during approximately 24 weeks.
Who may be eligible to participate?
Men or women diagnosed with PD at age ≥40 years who are currently being treated with a stable regimen of CD-LD but are experiencing motor fluctuations.
Patients must experience an average of at least 2.5 cumulative hours per day of “Off” time during waking hours to qualify.
Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center