A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Cabergoline; Levodopa

Criteria

Inclusion Criteria:

• 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 Criteria:

• Not available