Clinical Trial: Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients With Restless Legs Syndrome

Brief Summary: The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. [ Time Frame: 12 Weeks ]

Original Primary Outcome: The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.

Current Secondary Outcome: Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12. [ Time Frame: 12 Weeks ]

Original Secondary Outcome: Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12.

Information By: GlaxoSmithKline

Dates:
Date Received: September 13, 2005
Date Started: June 2005
Date Completion:
Last Updated: September 22, 2016
Last Verified: September 2016