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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ropinirole

Criteria

Inclusion criteria:

• provided written informed consent.

• Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.

• Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.

• Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

• Secondary RLS

• Primary sleep disorder

• Have any medical conditions that may impact efficacy assessments or that may present a safety concern.

• Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.

• Use of any prohibited medication.