12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome ((CR-RLS))

October 27, 2016 updated by: GlaxoSmithKline

A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep

The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

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
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • GSK Investigational Site
      • San Diego, California, United States, 92108
        • GSK Investigational Site
    • Colorado
      • Greenwood, Colorado, United States, 80111
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33707
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Austell, Georgia, United States, 30106
        • GSK Investigational Site
      • Macon, Georgia, United States, 31201
        • GSK Investigational Site
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • GSK Investigational Site
      • Normal, Illinois, United States, 61761
        • GSK Investigational Site
    • Indiana
      • Danville, Indiana, United States, 46122
        • GSK Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • GSK Investigational Site
      • Topeka, Kansas, United States, 66606
        • GSK Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40509
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40217
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • GSK Investigational Site
      • Lafayette, Louisiana, United States, 70503
        • GSK Investigational Site
    • Maine
      • Auburn, Maine, United States, 04210
        • GSK Investigational Site
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63143
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • GSK Investigational Site
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
      • Greenville, North Carolina, United States, 27835
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44195
        • GSK Investigational Site
      • Dublin, Ohio, United States, 43017
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • GSK Investigational Site
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • GSK Investigational Site
      • Portland, Oregon, United States, 97239
        • GSK Investigational Site
      • Portland, Oregon, United States, 97219
        • GSK Investigational Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • GSK Investigational Site
      • Lafayette Hill, Pennsylvania, United States, 19444
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75213
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • 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:

  • provided written informed consent.
  • Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS 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.
  • Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

  • Secondary RLS
  • Primary sleep disorder
  • Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
  • Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
  • Use of any prohibited medication.

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
Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes.
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

October 1, 2006

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

September 7, 2006

First Submitted That Met QC Criteria

September 7, 2006

First Posted (ESTIMATE)

September 8, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRL103660

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: RRL103660
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: RRL103660
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: RRL103660
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: RRL103660
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: RRL103660
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: RRL103660
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Clinical Study Report
    Information identifier: RRL103660
    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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