A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa

PHASE3CompletedINTERVENTIONAL
Enrollment

347

Participants

Timeline

Start Date

February 15, 2010

Primary Completion Date

September 1, 2011

Study Completion Date

September 29, 2011

Conditions
Parkinson Disease
Interventions
DRUG

ReQuip PR

If subjects are still eligible at the end of the placebo run-in period they will be randomized (1:1) to receive once daily doses of ropinirole PR or identical appearing placebo tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control. All subjects must be titrated to a minimum dose of 6 mg/day.

DRUG

Placebo

Placebo

Trial Locations (18)

100034

GSK Investigational Site, Beijing

100050

GSK Investigational Site, Beijing

100053

GSK Investigational Site, Beijing

100730

GSK Investigational Site, Beijing

100853

GSK Investigational Site, Beijing

200025

GSK Investigational Site, Shanghai

200032

GSK Investigational Site, Shanghai

200040

GSK Investigational Site, Shanghai

215004

GSK Investigational Site, Suzhou

300052

GSK Investigational Site, Tianjin

310009

GSK Investigational Site, Hangzhou

430022

GSK Investigational Site, Wuhan

510120

GSK Investigational Site, Guangzhou

610041

GSK Investigational Site, Chengdu

610072

GSK Investigational Site, Chengdu

650032

GSK Investigational Site, Kunming

650101

GSK Investigational Site, Kunming

710061

GSK Investigational Site, Xi'an

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01154166 - A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | Biotech Hunter | Biotech Hunter