Status:
COMPLETED
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Restless Legs Syndrome (RLS)
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
568 Patients enrolled
Trial Details
Trial ID
NCT00314860
Start Date
February 1 2006
End Date
December 1 2006
Last Update
October 18 2016
Active Locations (91)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35209
2
GSK Investigational Site
Mesa, Arizona, United States, 85210
3
GSK Investigational Site
Phoenix, Arizona, United States, 85050
4
GSK Investigational Site
Sun City, Arizona, United States, 85351