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

September 22, 2016 updated by: GlaxoSmithKline

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • GSK Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • GSK Investigational Site
      • Langley, British Columbia, Canada, V3A 4H9
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3J 3T1
        • GSK Investigational Site
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H2T 2N6
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
      • Trois Rivieres, Quebec, Canada, G8Z 4K4
        • GSK Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 0W5
        • GSK Investigational Site
  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • GSK Investigational Site
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85201
        • GSK Investigational Site
      • Peoria, Arizona, United States, 85381 - 4828
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85032
        • GSK Investigational Site
      • Sun City, Arizona, United States, 85351
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • GSK Investigational Site
      • Northridge, California, United States, 91325
        • GSK Investigational Site
      • Oxnard, California, United States, 93030
        • GSK Investigational Site
      • Pasadena, California, United States, 91105
        • GSK Investigational Site
      • Redondo Beach, California, United States, 90277
        • GSK Investigational Site
      • San Diego, California, United States, 92103
        • GSK Investigational Site
      • Santa Monica, California, United States, 90404
        • GSK Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • GSK Investigational Site
      • Denver, Colorado, United States, 80212
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Florida
      • Largo, Florida, United States, 33773
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • GSK Investigational Site
      • Stuart, Florida, United States, 34996
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30338
        • GSK Investigational Site
      • Austell, Georgia, United States, 30106
        • GSK Investigational Site
      • Dawsonville, Georgia, United States, 30534
        • GSK Investigational Site
      • Macon, Georgia, United States, 31201
        • GSK Investigational Site
      • Woodstock, Georgia, United States, 30189
        • GSK Investigational Site
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • GSK Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • GSK Investigational Site
      • Topeka, Kansas, United States, 66606
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • GSK Investigational Site
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • GSK Investigational Site
      • Endwell, New York, United States, 13760
        • GSK Investigational Site
      • Kingston, New York, United States, 12401
        • GSK Investigational Site
      • Schenectady, New York, United States, 12308
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44130
        • GSK Investigational Site
      • Dublin, Ohio, United States, 43017
        • GSK Investigational Site
      • Westerville, Ohio, United States, 43081
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97219
        • GSK Investigational Site
    • Pennsylvania
      • Lafayette Hill, Pennsylvania, United States, 19444
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464
        • GSK Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • GSK Investigational Site
      • Salt Lake City, Utah, United States, 84102
        • GSK Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • GSK Investigational Site
      • Charlottesville, Virginia, United States, 22911
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, United States, 98226
        • GSK Investigational Site
      • Renton, Washington, United States, 98055
        • GSK Investigational Site
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
      • Walla Walla, Washington, United States, 99362
        • GSK Investigational Site
      • Wenatchee, Washington, United States, 98801
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (ACTUAL)

January 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101468/205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: 101468/205
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 101468/205
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: 101468/205
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 101468/205
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 101468/205
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 101468/205
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: 101468/205
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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