Last updated: 11/02/2018 23:31:44

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

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GSK study ID
101468/205
See study documents
Clinicaltrials.gov ID
NCT00197080
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

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

Timeframe: 12 Weeks

Secondary outcomes:

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.

Timeframe: 12 Weeks

Interventions:
  • Drug: Ropinirole Extended Release (XR)
    • Enrollment:
    380
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Restless Legs Syndrome
    Product
    ropinirole
    Collaborators
    Not applicable
    Study date(s)
    June 2005 to January 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • 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.
    • Have secondary RLS.
    • Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

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

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-28-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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