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

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 Trial, MD, Study Director, Affiliation: GlaxoSmithKline

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.

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

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

Primary outcome: Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.

Secondary outcome: Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.

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

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.

GSK Clinical Trials Call Center, Birmingham, Alabama 35209, United States

GSK Clinical Trials Call Center, Birmingham, Alabama 35209, United States

GSK Clinical Trials Call Center, Jasper, Alabama 35501, United States

GSK Clinical Trials Call Center, Phoenix, Arizona 85032, United States

GSK Clinical Trials Call Center, Peoria, Arizona 85381, United States

GSK Clinical Trials Call Center, San Francisco, California 94109, United States

GSK Clinical Trials Call Center, Redondo Beach, California 90277, United States

GSK Clinical Trials Call Center, Oxnard, California 93030, United States

GSK Clinical Trials Call Center, Northridge, California 91325, United States

GSK Clinical Trials Call Center, Santa Monica, California 90404, United States

GSK Clinical Trials Call Center, Fairfield, Connecticut 06824, United States

GSK Clinical Trials Call Center, Tampa, Florida 33606, United States

GSK Clinical Trials Call Center, Pembroke Pines, Florida 33026, United States

GSK Clinical Trials Call Center, St. Petersburg, Florida 33701, United States

GSK Clinical Trials Call Center, Elk Grove Village, Illinois 60007, United States

GSK Clinical Trials Call Center, Chicago, Illinois 60611, United States

GSK Clinical Trials Call Center, Flossmoor, Illinois 60422, United States

GSK Clinical Trials Call Center, Topeka, Kansas 66606, United States

GSK Clinical Trials Call Center, Baton Rouge, Louisiana 70808, United States

GSK Clinical Trials Call Center, Frederick, Maryland 21702, United States

GSK Clinical Trials Call Center, Newton, Massachusetts 02459, United States

GSK Clinical Trials Call Center, Edison, New Jersey 08818, United States

GSK Clinical Trials Call Center, Albuquerque, New Mexico 87108, United States

GSK Clinical Trials Call Center, Albuquerque, New Mexico 87106, United States

GSK Clinical Trials Call Center, Amherst, New York 14226, United States

GSK Clinical Trials Call Center, Raleigh, North Carolina 27607, United States

GSK Clinical Trials Call Center, Cincinnati, Ohio 45219, United States

GSK Clinical Trials Call Center, Oklahoma City, Oklahoma 73112, United States

GSK Clinical Trials Call Center, Portland, Oregon 97239, United States

GSK Clinical Trials Call Center, Lafayette Hill, Pennsylvania 19444, United States

GSK Clinical Trials Call Center, Columbia, South Carolina 29201, United States

GSK Clinical Trials Call Center, San Antonio, Texas 78229, United States

GSK Clinical Trials Call Center, Austin, Texas 78756, United States

GSK Clinical Trials Call Center, Dallas, Texas 75093, United States

GSK Clinical Trials Call Center, Walla Walla, Washington 99362, United States

GSK Clinical Trials Call Center, Wenatchee, Washington 98801, United States

Starting date: January 2005
Last updated: June 26, 2007