Status:
COMPLETED
A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS
Lead Sponsor:
Pfizer
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS
- Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale
- No previous treatment for RLS or dissatisfaction with their current therapy
Exclusion
- Not available
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00625547
Start Date
January 1 2003
End Date
December 1 2004
Last Update
October 29 2008
Active Locations (50)
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1
Pfizer Investigational Site
Innsbruck, Austria, 6020
2
Pfizer Investigational Site
Vienna, Austria, A-1090
3
Pfizer Investigational Site
Altötting, Germany, 84503
4
Pfizer Investigational Site
Aschaffenburg, Germany, 63739