A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ropinirole

Criteria

 Inclusion criteria:

• Patients diagnosed with Restless Legs Syndrome (RLS).

• Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).

• Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

• Patients with a primary sleep disorder other than RLS.

• Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).

• Other inclusion or exclusion criteria to be evaluated by the physician.