Status:
COMPLETED
Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00197080
Start Date
June 1 2005
End Date
January 1 2006
Last Update
September 23 2016
Active Locations (70)
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1
GSK Investigational Site
Alabaster, Alabama, United States, 35007
2
GSK Investigational Site
Jasper, Alabama, United States, 35501
3
GSK Investigational Site
Mesa, Arizona, United States, 85201
4
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828