Last updated: 11/02/2018 23:35:00

A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

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GSK study ID
101468/249
See study documents
Clinicaltrials.gov ID
NCT00363857
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 in Patients Suffering from Restless Legs Syndrome (RLS)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Ropinirole
    • Enrollment:
    360
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Restless Legs Syndrome (RLS)
    Product
    ropinirole
    Collaborators
    Not applicable
    Study date(s)
    August 2003 to May 2004
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 79 years
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion criteria
    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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Jasper, Alabama, United States, 35501
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43210-1296
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30329
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plano, Texas, United States, 75093
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    La Jolla, California, United States, 92037
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Schenectady, New York, United States, 12308
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Northridge, California, United States, 91325
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oxnard, California, United States, 93030
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97201
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    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
    Birmingham, Alabama, United States, 35294
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33026
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23507
    Status
    Terminated/Withdrawn
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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
    Stanford, California, United States, 94305-5548
    Status
    Terminated/Withdrawn
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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
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Elk Grove Village, Illinois, United States, 60007
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tuscaloosa, Alabama, United States, 35406
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lafayette Hill, Pennsylvania, United States, 19444
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78756
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37205
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Augusta, Georgia, United States, 30912
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berkeley, California, United States, 94705
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85032
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Henderson, Nevada, United States, 89052
    Status
    Terminated/Withdrawn
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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
    Danbury, Connecticut, United States, 06810
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lebanon, New Hampshire, United States, 03766
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Southfield, Michigan, United States, 48034
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Concinnati, Ohio, United States, 45219
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75231
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85050
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Alexandria, Virginia, United States, 22311
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33609
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dublin, Ohio, United States, 43017
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33701
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40217
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Largo, Florida, United States, 33773
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Aurora, Colorado, United States, 80012
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60611
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Walla Walla, Washington, United States, 99362
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Santa Monica, California, United States, 90404
    Status
    Terminated/Withdrawn
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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
    Boca Raton, Florida, United States, 33486
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Redondo Beach, California, United States, 90277
    Status
    Terminated/Withdrawn
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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
    2004-17-05

    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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