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

NCT00197080 | Completed Phase 3

• 1 other identifier: 101468/205
• Study Type: interventional
• Target: 380
• Locations: 2 countries
• Sites: 70

Brief 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).

Conditions

Restless Legs Syndrome

Keywords

Restless Legs Syndrome; RLS

Outcome Measures

Primary Outcomes (1)

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

  12 Weeks

Secondary Outcomes (1)

• 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.

  12 Weeks

Interventions

Ropinirole Extended Release (XR) DRUG

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Have secondary RLS.
• Have any medical conditions that may impact efficacy assessments or that may present a safety concern.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (70)

GSK Investigational Site

Alabaster, Alabama, 35007, United States

Location

GSK Investigational Site

Jasper, Alabama, 35501, United States

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GSK Investigational Site

Mesa, Arizona, 85201, United States

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GSK Investigational Site

Peoria, Arizona, 85381 - 4828, United States

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Phoenix, Arizona, 85032, United States

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GSK Investigational Site

Sun City, Arizona, 85351, United States

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Anaheim, California, 92801, United States

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Northridge, California, 91325, United States

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Oxnard, California, 93030, United States

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Pasadena, California, 91105, United States

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GSK Investigational Site

Redondo Beach, California, 90277, United States

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San Diego, California, 92103, United States

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Santa Monica, California, 90404, United States

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GSK Investigational Site

Colorado Springs, Colorado, 80909, United States

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GSK Investigational Site

Denver, Colorado, 80212, United States

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Wheat Ridge, Colorado, 80033, United States

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Largo, Florida, 33773, United States

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Pembroke Pines, Florida, 33026, United States

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Stuart, Florida, 34996, United States

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Atlanta, Georgia, 30338, United States

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GSK Investigational Site

Atlanta, Georgia, 30342, United States

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Austell, Georgia, 30106, United States

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Dawsonville, Georgia, 30534, United States

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Macon, Georgia, 31201, United States

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GSK Investigational Site

Woodstock, Georgia, 30189, United States

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Northbrook, Illinois, 60062, United States

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Lenexa, Kansas, 66214, United States

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GSK Investigational Site

Topeka, Kansas, 66606, United States

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GSK Investigational Site

Louisville, Kentucky, 40217, United States

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Baton Rouge, Louisiana, 70808, United States

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Newton, Massachusetts, 02459, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89119, United States

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Albuquerque, New Mexico, 87108, United States

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GSK Investigational Site

Albany, New York, 12205, United States

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GSK Investigational Site

Endwell, New York, 13760, United States

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GSK Investigational Site

Kingston, New York, 12401, United States

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Schenectady, New York, 12308, United States

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Raleigh, North Carolina, 27607, United States

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GSK Investigational Site

Cincinnati, Ohio, 45236, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44130, United States

Location

GSK Investigational Site

Dublin, Ohio, 43017, United States

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GSK Investigational Site

Westerville, Ohio, 43081, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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GSK Investigational Site

Portland, Oregon, 97219, United States

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GSK Investigational Site

Lafayette Hill, Pennsylvania, 19444, United States

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GSK Investigational Site

Columbia, South Carolina, 29201, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

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Jackson, Tennessee, 38305, United States

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GSK Investigational Site

Dallas, Texas, 75231, United States

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GSK Investigational Site

San Antonio, Texas, 78229, United States

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GSK Investigational Site

Salt Lake City, Utah, 84102, United States

Location

GSK Investigational Site

Salt Lake City, Utah, 84121, United States

Location

GSK Investigational Site

Alexandria, Virginia, 22311, United States

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GSK Investigational Site

Charlottesville, Virginia, 22911, United States

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GSK Investigational Site

Bellingham, Washington, 98226, United States

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GSK Investigational Site

Renton, Washington, 98055, United States

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GSK Investigational Site

Spokane, Washington, 99204, United States

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GSK Investigational Site

Walla Walla, Washington, 99362, United States

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GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

GSK Investigational Site

Edmonton, Alberta, T6G 2C8, Canada

Location

GSK Investigational Site

Coquitlam, British Columbia, V3K 3P4, Canada

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GSK Investigational Site

Langley, British Columbia, V3A 4H9, Canada

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GSK Investigational Site

Halifax, Nova Scotia, B3J 3T1, Canada

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GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

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GSK Investigational Site

Montreal, Quebec, H2T 2N6, Canada

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GSK Investigational Site

Montreal, Quebec, H4J 1C5, Canada

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GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

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GSK Investigational Site

Trois-Rivières, Quebec, G8Z 4K4, Canada

Location

GSK Investigational Site

Regina, Saskatchewan, S4P 0W5, Canada

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2005
• Study Completion: January 1, 2006
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (10); US (60)