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Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Restless Legs Syndrome; Restless Legs Syndrome (RLS)

Intervention: Ropinirole Extended Release (XR) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

Summary

The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.

Secondary outcome: Assess safety, tolerability, and patient-reported outcomes, including changes in the Clinical Global Impression Scale Scores and changes in the Medical Outcomes Study Sleep Scale at Week 12.

Eligibility

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

Criteria:

Inclusion criteria:

- Diagnosed with RLS using the International RLS Study Group Diagnostic Criteria with a

total score of 15 or greater on the International RLS Rating Scale.

- Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS

symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5: 00PM. Exclusion criteria:

- Have secondary RLS.

- Have any medical conditions that may impact efficacy assessments or that may present

a safety concern.

Locations and Contacts

GSK Investigational Site, Alabaster, Alabama 35007, United States

GSK Investigational Site, Jasper, Alabama 35501, United States

GSK Investigational Site, Edmonton, Alberta T6G 2C8, Canada

GSK Investigational Site, Mesa, Arizona 85201, United States

GSK Investigational Site, Peoria, Arizona 85381 - 4828, United States

GSK Investigational Site, Phoenix, Arizona 85032, United States

GSK Investigational Site, Sun City, Arizona 85351, United States

GSK Investigational Site, Coquitlam, British Columbia V3K 3P4, Canada

GSK Investigational Site, Langley, British Columbia V3A 4H9, Canada

GSK Investigational Site, Northridge, California 91325, United States

GSK Investigational Site, Oxnard, California 93030, United States

GSK Investigational Site, Pasadena, California 91105, United States

GSK Investigational Site, Redondo Beach, California 90277, United States

GSK Investigational Site, San Diego, California 92103, United States

GSK Investigational Site, Santa Monica, California 90404, United States

GSK Investigational Site, Colorado Springs, Colorado 80909, United States

GSK Investigational Site, Denver, Colorado 80212, United States

GSK Investigational Site, Wheat Ridge, Colorado 80033, United States

GSK Investigational Site, Largo, Florida 33773, United States

GSK Investigational Site, Pembroke Pines, Florida 33026, United States

GSK Investigational Site, Stuart, Florida 34996, United States

GSK Investigational Site, Atlanta, Georgia 30338, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Austell, Georgia 30106, United States

GSK Investigational Site, Dawsonville, Georgia 30534, United States

GSK Investigational Site, Macon, Georgia 31201, United States

GSK Investigational Site, Woodstock, Georgia 30189, United States

GSK Investigational Site, Northbrook, Illinois 60062, United States

GSK Investigational Site, Lenexa, Kansas 66214, United States

GSK Investigational Site, Topeka, Kansas 66606, United States

GSK Investigational Site, Louisville, Kentucky 40217, United States

GSK Investigational Site, Baton Rouge, Louisiana 70808, United States

GSK Investigational Site, Newton, Massachusetts 02459, United States

GSK Investigational Site, Las Vegas, Nevada 89119, United States

GSK Investigational Site, Albuquerque, New Mexico 87108, United States

GSK Investigational Site, Albany, New York 12205, United States

GSK Investigational Site, Endwell, New York 13760, United States

GSK Investigational Site, Kingston, New York 12401, United States

GSK Investigational Site, Schenectady, New York 12308, United States

GSK Investigational Site, Raleigh, North Carolina 27607, United States

GSK Investigational Site, Halifax, Nova Scotia B3J 3T1, Canada

GSK Investigational Site, Cincinnati, Ohio 45236, United States

GSK Investigational Site, Cleveland, Ohio 44130, United States

GSK Investigational Site, Dublin, Ohio 43017, United States

GSK Investigational Site, Westerville, Ohio 43081, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73112, United States

GSK Investigational Site, Ajax, Ontario L1S 2J5, Canada

GSK Investigational Site, Portland, Oregon 97219, United States

GSK Investigational Site, Lafayette Hill, Pennsylvania 19444, United States

GSK Investigational Site, Montreal, Quebec H2T 2N6, Canada

GSK Investigational Site, Montreal, Quebec H4J 1C5, Canada

GSK Investigational Site, Sherbrooke, Quebec J1H 1Z1, Canada

GSK Investigational Site, Trois Rivieres, Quebec G8Z 4K4, Canada

GSK Investigational Site, Regina, Saskatchewan S4P 0W5, Canada

GSK Investigational Site, Columbia, South Carolina 29201, United States

GSK Investigational Site, Mount Pleasant, South Carolina 29464, United States

GSK Investigational Site, Jackson, Tennessee 38305, United States

GSK Investigational Site, Dallas, Texas 75231, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, Salt Lake City, Utah 84121, United States

GSK Investigational Site, Salt Lake City, Utah 84102, United States

GSK Investigational Site, Alexandria, Virginia 22311, United States

GSK Investigational Site, Charlottesville, Virginia 22911, United States

GSK Investigational Site, Bellingham, Washington 98226, United States

GSK Investigational Site, Renton, Washington 98055, United States

GSK Investigational Site, Spokane, Washington 99204, United States

GSK Investigational Site, Walla Walla, Washington 99362, United States

GSK Investigational Site, Wenatchee, Washington 98801, United States

Additional Information

Starting date: June 2005
Last updated: February 13, 2013

Page last updated: August 23, 2015

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