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

Completed · Phase 4

Conditions studied: Restless Legs Syndrome (RLS), Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT00373542

Run by

GlaxoSmithKline

People needed

39

Starts

2006-10-01

Expected to finish

2007-06-01

Last updated by the study team

2016-10-28

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Tuscaloosa, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Greenwood, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — Brandon, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — St. Petersburg, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Austell, Georgia, United States
• GSK Investigational Site — Macon, Georgia, United States
• GSK Investigational Site — Elk Grove Village, Illinois, United States
• GSK Investigational Site — Normal, Illinois, United States
• GSK Investigational Site — Danville, Indiana, United States
• GSK Investigational Site — Lenexa, Kansas, United States
• GSK Investigational Site — Topeka, Kansas, United States
• GSK Investigational Site — Crestview Hills, Kentucky, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Baton Rouge, Louisiana, United States
• GSK Investigational Site — Lafayette, Louisiana, United States
• GSK Investigational Site — Auburn, Maine, United States

Full record on ClinicalTrials.gov

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