A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Phase 3

Completed

• Conditions: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

• Registration Number: NCT00363857
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in RLS severity rating scale at Week 12

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Walla Walla, Washington, United States