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

Completed · Phase 3

Conditions studied: Restless Legs Syndrome

In brief

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).

Key facts

Study ID

NCT00197080

Run by

GlaxoSmithKline

People needed

380

Starts

2005-06-01

Expected to finish

2006-01-01

Last updated by the study team

2016-09-23

Who can join

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

You may qualify if…

• Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS 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.

You may not qualify if…

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

Where it is running

• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Mesa, Arizona, United States
• GSK Investigational Site — Peoria, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Sun City, Arizona, United States
• GSK Investigational Site — Anaheim, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — Oxnard, California, United States
• GSK Investigational Site — Pasadena, California, United States
• GSK Investigational Site — Redondo Beach, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Colorado Springs, Colorado, United States
• GSK Investigational Site — Denver, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — Largo, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — Stuart, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Austell, Georgia, United States
• GSK Investigational Site — Dawsonville, Georgia, United States
• GSK Investigational Site — Macon, Georgia, United States
• GSK Investigational Site — Woodstock, Georgia, United States
• GSK Investigational Site — Alabaster, Alabama, United States

Full record on ClinicalTrials.gov

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