Last updated: 11/06/2018 23:16:11

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

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GSK study ID
100310
See study documents
Clinicaltrials.gov ID
NCT00225862
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 intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS)
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

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.

Timeframe: 12 Weeks

Secondary outcomes:

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

Timeframe: 12 Weeks

Interventions:
  • Drug: ropinirole
    • Enrollment:
    140
    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)
    January 2005 to December 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

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

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Newton, Massachusetts, United States, 02459
    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
    Jasper, Alabama, United States, 35501
    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
    Flossmoor, Illinois, United States, 60422
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Edison, New Jersey, United States, 08818
    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
    2005-07-12

    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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