RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
Phase 3
Completed
- Conditions
- Restless Legs Syndrome (RLS)Restless Legs Syndrome
- Registration Number
- NCT00314860
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 568
Inclusion Criteria
- 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.
Exclusion criteria:
- 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.
Read More
Exclusion Criteria
Not provided
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 12 Weeks
- Secondary Outcome Measures
Name Time Method 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. 12 Weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Ledbury, United Kingdom