Clinical Trial: A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

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 Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome

Brief Summary: A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase. [ Time Frame: 12 Weeks ]

Original Primary Outcome: Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.

Current Secondary Outcome: Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication. [ Time Frame: 12 Weeks ]

Original Secondary Outcome: Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.

Information By: GlaxoSmithKline

Dates:
Date Received: June 30, 2005
Date Started: January 2005
Date Completion:
Last Updated: September 13, 2016
Last Verified: September 2016