A Two Year Phase IIIb Randomised, Multicenter, Double-blind, SINEMET Controlled, Parallel Group, Flexible Dose Study, to Assess the Effectiveness of Controlled Release Ropinirole add-on Therapy to L-dopa at Increasing the Time to Onset of Dyskinesia in Parkinson's Disease Subjects.

NCT00363727 Phase 3 COMPLETED

This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.

Details

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	COMPLETED
Enrolment	209
Start date	2003-12
Completion	2006-01

Conditions

• Parkinson's Disease
• Parkinson Disease
• Dyskinesias

Interventions

• ropinirole controlled-release (REQUIP CR) for RLS

Primary outcomes

• Number of participants with time to onset of dyskinesia of treatment over 104 weeks (2 years) — Up to 2 Years
  Median time to dyskinesia could not be estimated by Kaplan-Meier methods because of the small number of events; however, number of participants with dyskinesia requiring days from the date of randomization (Day 1) to the date at which a participant has the event of interest were reported

Countries

United States