Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

Completed · Phase 3 · Has a placebo group

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

In brief

The purpose of this study is to assess the efficacy and safety of GSK1838262 extended release tablets in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance.

Key facts

Study ID

NCT00748098

Run by

XenoPort, Inc.

People needed

136

Starts

2008-10-01

Expected to finish

2009-07-01

Last updated by the study team

2013-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provided written informed consent.
• Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 15 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
• Have history of RLS symptoms at least 15 nights/month.
• Minimum average of 15 Periodic Limb Movements during Sleep per hour (measured using actigraphy).

You may not qualify if…

• Secondary RLS
• Primary sleep disorder
• Sleep apnea
• Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
• Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
• Use of any prohibited medication.

Where it is running

• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Hallandale, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Macon, Georgia, United States
• GSK Investigational Site — Lenexa, Kansas, United States
• GSK Investigational Site — Overland Park, Kansas, United States
• GSK Investigational Site — Crestview Hills, Kentucky, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Chevy Chase, Maryland, United States
• GSK Investigational Site — Brighton, Massachusetts, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — West Seneca, New York, United States
• GSK Investigational Site — Greenville, North Carolina, United States
• GSK Investigational Site — Raleigh, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Dublin, Ohio, United States
• GSK Investigational Site — Oklahoma City, Oklahoma, United States
• GSK Investigational Site — Columbia, South Carolina, United States
• GSK Investigational Site — Austin, Texas, United States
• GSK Investigational Site — Walla Walla, Washington, United States

Full record on ClinicalTrials.gov

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