Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)

PHASE2CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

April 9, 2007

Primary Completion Date

March 1, 2009

Study Completion Date

March 10, 2009

Conditions
Parkinson Disease
Interventions
DRUG

Ropinirole prolonged release/extended release(PR/XR)

Subjects will take the investigational drug once daily at the same time each day, it is recommended that this is in the morning for optimal benefit. Investigational drug is taken for 52 weeks, starting on the next day of the Week 0 visit. One tablet of ropinirole PR/XR 2 mg tablets will be orally dosed as the initial dose. The dose will be titrated weekly by 2 mg/day, and increased to 8 mg/day in Week 4. From Week 5 up to 16, the dose will be increased at minimum intervals of one week between titration steps until sufficient efficacy is obtained, according to individual clinical response and tolerability (the dose may be titrated up to 16 mg/day). In Week 16 and further, treatment dose at Week 16 will be continuously administered up to Week 52. If insufficient efficacy is judged in a subject during treatment, or unable to maintain the dose due to adverse event, the treatment dose may be changed. The dose is down tapered according to the maintenance dose at Week 52 (or withdrawal).

Trial Locations (12)

455-8530

GSK Investigational Site, Aichi

460-0008

GSK Investigational Site, Aichi

279-0021

GSK Investigational Site, Chiba

791-0295

GSK Investigational Site, Ehime

070-0901

GSK Investigational Site, Hokkaido

251-0038

GSK Investigational Site, Kanagawa

600-8811

GSK Investigational Site, Kyoto

020-0878

GSK Investigational Site, Numakunai

570-8507

GSK Investigational Site, Osaka

343-0032

GSK Investigational Site, Saitama

113-8431

GSK Investigational Site, Tokyo

136-0075

GSK Investigational Site, Tokyo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY