Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
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The primary endpoint is the change from baseline in the International RLS Study Group Rating Scale total score at Week 12. [ Time Frame: 12 Weeks ]
Secondary Outcome Measures
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. [ Time Frame: 12 Weeks ]
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Ages Eligible for Study:
18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.