REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study

PHASE4CompletedINTERVENTIONAL
Enrollment

123

Participants

Timeline

Start Date

June 30, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Parkinson DiseaseParkinson's Disease
Interventions
DRUG

ROP

Ropinirole Hydrochloride monotherapy group (ROP): Patients will receive ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 mg/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. Concomitant use of L-dopa is prohibited during the study.

DRUG

ROP+L-Dopa

Ropinirole Hydrochloride with L-Dopa adjunct therapy group (ROP+L-Dopa): Patients will receive ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose will start at 0.75 milligrams (mg)/day and will be increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose will be increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose will be maintained at a level without further symptomatic improvement is expected. The dosing regimen of L-dopa remain unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.

Trial Locations (22)

270-2251

GSK Investigational Site, Chiba

814-0180

GSK Investigational Site, Fukuoka

816-0943

GSK Investigational Site, Fukuoka

819-8585

GSK Investigational Site, Fukuoka

651-2273

GSK Investigational Site, Hyōgo

300-0053

GSK Investigational Site, Ibaraki

247-8533

GSK Investigational Site, Kanagawa

253-8558

GSK Investigational Site, Kanagawa

616-8255

GSK Investigational Site, Kyoto

982-8555

GSK Investigational Site, Miyagi

989-2202

GSK Investigational Site, Miyagi

020-8505

GSK Investigational Site, Numakunai

543-8555

GSK Investigational Site, Osaka

558-8558

GSK Investigational Site, Osaka

578-8588

GSK Investigational Site, Osaka

590-0132

GSK Investigational Site, Osaka

598-0048

GSK Investigational Site, Osaka

849-8501

GSK Investigational Site, Saga

364-8501

GSK Investigational Site, Saitama

154-8551

GSK Investigational Site, Tokyo

160-0017

GSK Investigational Site, Tokyo

187-8551

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY