A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

October 14, 2016 updated by: GlaxoSmithKline

A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering From Restless Legs Syndrome (RLS)

A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the United States.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

360

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

  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35294
        • GSK Investigational Site
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85032
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Berkeley, California, United States, 94705
        • GSK Investigational Site
      • La Jolla, California, United States, 92037
        • GSK Investigational Site
      • Northridge, California, United States, 91325
        • GSK Investigational Site
      • Oxnard, California, United States, 93030
        • GSK Investigational Site
      • Redondo Beach, California, United States, 90277
        • GSK Investigational Site
      • Santa Monica, California, United States, 90404
        • GSK Investigational Site
      • Stanford, California, United States, 94305-5548
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • GSK Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • GSK Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • GSK Investigational Site
      • Largo, Florida, United States, 33773
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • GSK Investigational Site
      • Tampa, Florida, United States, 33606
        • GSK Investigational Site
      • Tampa, Florida, United States, 33609
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • GSK Investigational Site
      • Augusta, Georgia, United States, 30912
        • GSK Investigational Site
      • Macon, Georgia, United States, 31201
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • GSK Investigational Site
      • Elk Grove Village, Illinois, United States, 60007
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • GSK Investigational Site
    • Michigan
      • Southfield, Michigan, United States, 48034
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • GSK Investigational Site
    • New York
      • Schenectady, New York, United States, 12308
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43210-1296
        • GSK Investigational Site
      • Concinnati, Ohio, United States, 45219
        • GSK Investigational Site
      • Dublin, Ohio, United States, 43017
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97201
        • GSK Investigational Site
    • Pennsylvania
      • Lafayette Hill, Pennsylvania, United States, 19444
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Dallas, Texas, United States, 75231
        • GSK Investigational Site
      • Plano, Texas, United States, 75093
        • GSK Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22311
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23507
        • GSK Investigational Site
    • Washington
      • Walla Walla, Washington, United States, 99362
        • 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:

  • Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
  • Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

  • Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
  • Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
  • Patients suffering from other movement disorders (i.e. Parkinson's Disease).
  • Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
  • Participation in any clinical drug or device trial in the last three months.

Other inclusion or exclusion criteria to be evaluated by the physician.

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
Improvement in RLS severity rating scale at Week 12

Secondary Outcome Measures

Outcome Measure
Percentage of patients who were much improved or very much improved on an overall clinical rating scale at Week 12.

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

August 1, 2003

Primary Completion (ACTUAL)

May 1, 2004

Study Completion (ACTUAL)

May 1, 2004

Study Registration Dates

First Submitted

August 11, 2006

First Submitted That Met QC Criteria

August 11, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2016

Last Update Submitted That Met QC Criteria

October 14, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101468/249

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. Informed Consent Form
    Information identifier: 101468/249
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 101468/249
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 101468/249
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 101468/249
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: 101468/249
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: 101468/249
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Statistical Analysis Plan
    Information identifier: 101468/249
    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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