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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Parkinson Disease; Parkinson's Disease; Dyskinesias

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00363727

101468/228

Details and patient eligibility

About

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.

Enrollment: 209 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind