A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Completed · Phase 3

Conditions studied: Restless Legs Syndrome (RLS), Restless Legs Syndrome

In brief

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.

Key facts

Study ID

NCT00363857

Run by

GlaxoSmithKline

People needed

360

Starts

2003-08-01

Expected to finish

2004-05-01

Last updated by the study team

2016-10-17

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Alabaster, Alabama, United States
• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Tuscaloosa, Alabama, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Berkeley, California, United States
• GSK Investigational Site — La Jolla, California, United States
• GSK Investigational Site — Northridge, California, United States
• GSK Investigational Site — Oxnard, California, United States
• GSK Investigational Site — Redondo Beach, California, United States
• GSK Investigational Site — Santa Monica, California, United States
• GSK Investigational Site — Stanford, California, United States
• GSK Investigational Site — Aurora, Colorado, United States
• GSK Investigational Site — Danbury, Connecticut, United States
• GSK Investigational Site — Boca Raton, Florida, United States
• GSK Investigational Site — Largo, Florida, United States
• GSK Investigational Site — Pembroke Pines, Florida, United States
• GSK Investigational Site — St. Petersburg, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — Macon, Georgia, United States

Full record on ClinicalTrials.gov

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