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

A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Drug: cabergoline; Drug: levodopa

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Pfizer Investigational Site
  • Wien, Austria, A-1090
    • Pfizer Investigational Site
• Germany
  • Altoetting, Germany, 84503
    • Pfizer Investigational Site
  • Aschaffenburg, Germany, 63739
    • Pfizer Investigational Site
  • Bad Honnef, Germany, 53604
    • Pfizer Investigational Site
  • Bad Saarow, Germany, 15526
    • Pfizer Investigational Site
  • Beckum, Germany, 49269
    • Pfizer Investigational Site
  • Berlin, Germany, 10969
    • Pfizer Investigational Site
  • Berlin, Germany, 12163
    • Pfizer Investigational Site
  • Berlin, Germany, 12687
    • Pfizer Investigational Site
  • Berlin, Germany, 13053
    • Pfizer Investigational Site
  • Berlin, Germany, 13507
    • Pfizer Investigational Site
  • Bochum, Germany
    • Pfizer Investigational Site
  • Bremerhaven, Germany, 27568
    • Pfizer Investigational Site
  • Dillingen, Germany, 66763
    • Pfizer Investigational Site
  • Duesseldorf, Germany, 40211
    • Pfizer Investigational Site
  • Duisburg, Germany
    • Pfizer Investigational Site
  • Gelsenkirchen, Germany, 45891
    • Pfizer Investigational Site
  • Gera, Germany, 0755
    • Pfizer Investigational Site
  • Goettingen, Germany, 37075
    • Pfizer Investigational Site
  • Goettingen, Germany, 37037
    • Pfizer Investigational Site
  • Halle, Germany, 06118
    • Pfizer Investigational Site
  • Hamburg, Germany, 22359
    • Pfizer Investigational Site
  • Heilbronn, Germany, 74072
    • Pfizer Investigational Site
  • Jena, Germany
    • Pfizer Investigational Site
  • Kaiserslautern, Germany, 67655
    • Pfizer Investigational Site
  • Karlsruhe, Germany, 76137
    • Pfizer Investigational Site
  • Karlsruhe, Germany
    • Pfizer Investigational Site
  • Kassel, Germany, 34128
    • Pfizer Investigational Site
  • Köthen, Germany
    • Pfizer Investigational Site
  • Marburg, Germany, 35039
    • Pfizer Investigational Site
  • Mittweida, Germany, 09648
    • Pfizer Investigational Site
  • Moenchengladbach, Germany, 41179
    • Pfizer Investigational Site
  • Neubrandenburg, Germany, 17033
    • Pfizer Investigational Site
  • Oldenburg, Germany, 26122
    • Pfizer Investigational Site
  • Quickborn, Germany, 25451
    • Pfizer Investigational Site
  • Regensburg, Germany, 93053
    • Pfizer Investigational Site
  • Schwalmstadt, Germany, 34613
    • Pfizer Investigational Site
  • Schwerin, Germany, 19055
    • Pfizer Investigational Site
  • Stuttgart, Germany, 70176
    • Pfizer Investigational Site
  • Tuttlingen, Germany, 78532
    • Pfizer Investigational Site
  • Ulm, Germany, 89073
    • Pfizer Investigational Site
  • Wiesbaden, Germany, 65191
    • Pfizer Investigational Site
  • Wolfsburg, Germany
    • Pfizer Investigational Site
• Sweden
  • Goteborg, Sweden, S-413 45
    • Pfizer Investigational Site
  • Karlstad, Sweden
    • Pfizer Investigational Site
  • Linköping, Sweden, 581 85
    • Pfizer Investigational Site
• Switzerland
  • Basel, Switzerland, 4031
    • Pfizer Investigational Site
  • Bern, Switzerland
    • Pfizer Investigational Site
  • Zürich, Switzerland, CH-8091
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: cabergoline; Cabergoline oral tablets: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events
Experimental: 2	Drug: levodopa; Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 27, 2008
• First Posted (Estimate): February 28, 2008

Study Record Updates

• Last Update Posted (Estimate): October 29, 2008
• Last Update Submitted That Met QC Criteria: October 28, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Levodopa; Cabergoline
• Other Study ID Numbers: CABAS-0067-031