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

Phase 3

Completed

• Conditions: Restless Legs Syndrome

• Registration Number: NCT00197080
• Lead Sponsor: GlaxoSmithKline

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 Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
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.	12 Weeks

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇦 Regina, Saskatchewan, Canada