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

A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome

Request patient level data
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
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Jasper, Alabama, United States, 35501
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43210-1296
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30329
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Plano, Texas, United States, 75093
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    La Jolla, California, United States, 92037
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Schenectady, New York, United States, 12308
    Status
    Terminated/Withdrawn
    Contact us
    Showing 1 - 6 of 49 Results

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website