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

Phase 3

Completed

• Conditions: Restless Legs Syndrome
• Interventions: Drug: cabergoline; Drug: levodopa

• Registration Number: NCT00625547
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2004-12
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-02-28
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-28
• Last Update Posted: 2008-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 361

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cabergoline	-
2	levodopa	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)	Week 6
Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period)

Secondary Outcome Measures

Name	Time	Method
RLS quality-of-life questionnaire	Weeks 6 and 30
Clinical Global Impression	Weeks 6 and 30
Patient Global Impression	Weeks 6 and 30
Sleep questionnaire form A	Weeks 6 and 30
IRLSSG-RS	Week 30
Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram	Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2
Rating of severity of RLS at night (RLS-6 scale)	Weeks 6 and 30
Rating of severity of RLS before bedtime (RLS-6 scale)	Weeks 6 and 30
Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)	Weeks 6 and 30
Global rating of quality of sleep (RLS-6 scale)	Weeks 6 and 30

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇭 Zürich, Switzerland