A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Restless Legs Syndrome

Restless Legs Syndrome (RLS)

Treatments

Drug: Ropinirole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00363857

101468/249

Details and patient eligibility

About

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Enrollment

360 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria

Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
Patients suffering from other movement disorders (i.e. Parkinson's Disease).
Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
Participation in any clinical drug or device trial in the last three months.

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