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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: ropinirole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00225862

100310

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind