12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

Phase 4

Completed

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

• Registration Number: NCT00373542
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Study Start: 2006-10
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.	12 Weeks

Trial Locations

Locations (1)

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