Status:
COMPLETED
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- provided written informed consent.
- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS 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.
- Sleep efficiency \<85% OR Latency to persistent sleep \>20 minutes.
- Exclusion criteria:
- Secondary RLS
- Primary sleep disorder
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
- Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
- Use of any prohibited medication.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00373542
Start Date
October 1 2006
End Date
June 1 2007
Last Update
October 28 2016
Active Locations (45)
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1
GSK Investigational Site
Jasper, Alabama, United States, 35501
2
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
3
GSK Investigational Site
Phoenix, Arizona, United States, 85006
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72205