RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
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A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared With Ropinirole Immediate Release (IR) Tablets in Subjects With Restless Legs Syndrome (RLS)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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To demonstrate the superior tolerability of ropinirole extended release compared to ropinirole immediate release in adult subjects with RLS requiring evening and night-time coverage of RLS symptoms [ Time Frame: 12 Weeks ]
Secondary Outcome Measures :
To compare the safety profile and to evaluate the clinical benefits (as assessed by efficacy endpoints and patient-reported outcomes) of ropinirole extended release compared to ropinirole immediate release in subjects with RLS. [ Time Frame: 12 Weeks ]
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Ages Eligible for Study:
18 Years to 79 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.
Signs of secondary RLS.
Primary sleep disorder or movement disorder other than RLS.
Unstable medical conditions.
Inability to tolerate dopamine agonists or dopamine antagonists.
Unwilling to discontinue any medications currently being taken to treat RLS symptoms.