Parkinson's Disease Clinical Trial
Official title:
Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects
Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.
Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation
treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal
gel (LCIG) in the treatment of participants with levodopa-responsive Parkinson's disease
(PD) with persistent motor fluctuations despite optimized treatment with available PD
medications. All participants received LCIG.
Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study
S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this
12-month continuation treatment study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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