A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Condition(s) targeted: Restless Legs Syndrome

Intervention: Ropinirole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Improvement in RLS severity rating scale at Week 12

Secondary outcome: Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.

Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

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.

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Starting date: September 2003
Last updated: August 11, 2006