A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

September 13, 2016 updated by: GlaxoSmithKline

A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

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
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381 - 4828
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85032
        • GSK Investigational Site
    • California
      • 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
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • GSK Investigational Site
    • Florida
      • 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
    • Illinois
      • Chicago, Illinois, United States, 60611
        • GSK Investigational Site
      • Elk Grove Village, Illinois, United States, 60007
        • GSK Investigational Site
      • Flossmoor, Illinois, United States, 60422
        • GSK Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • GSK Investigational Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • GSK Investigational Site
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • GSK Investigational Site
      • Newton Center, Massachusetts, United States, 02459
        • GSK Investigational Site
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • GSK Investigational Site
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • GSK Investigational Site
      • Albuquerque, New Mexico, United States, 87108
        • GSK Investigational Site
    • New York
      • Amherst, New York, United States, 14226
        • GSK Investigational Site
      • New Hyde Park, New York, United States, 11040
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
    • Ohio
      • Concinnati, Ohio, United States, 45219
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Pennsylvania
      • Lafayette Hill, Pennsylvania, United States, 19444
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Plano, Texas, United States, 75093
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Washington
      • 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:

  • Patients diagnosed with Restless Legs Syndrome (RLS).
  • Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
  • Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

  • Patients with a primary sleep disorder other than RLS.
  • Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
  • 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 Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.
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

January 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100310

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. Statistical Analysis Plan
    Information identifier: 100310
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Annotated Case Report Form
    Information identifier: 100310
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 100310
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 100310
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 100310
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: 100310
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Study Protocol
    Information identifier: 100310
    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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