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
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    Contact us
    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
    Contact us
    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Stuart, Florida, United States, 34996
    Status
    Study Complete
    Contact us
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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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