Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-Release) As Add-on Therapy To L-Dopa In Parkinson's

Condition(s) targeted: Parkinson's Disease; Dyskinesias

Intervention: ropinirole controlled-release (REQUIP CR) for RLS (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: 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.

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to onset of dyskinesia over 2 years of treatment.

Secondary outcome: UPDRS Incidence of dyskinesia ESS CGI PDQ39 change from baseline MMSE score BDI PDSS Frequency of variants within genes of interest between subjects with and without dyskinesia.

Minimum age: 30 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must be on 600mg or less of levodopa therapy for two years or less.

- Must be on a stable dose of levodopa therapy for at least 4 weeks prior to screening.

Exclusion Criteria:

- Current or past history of Dyskinesia.

- State of dementia or have a MMSE score < 26 at screening.

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Starting date: December 2005
Last updated: September 6, 2007