Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Change from baseline in the total score of the International RLS Study Group Rating Scale (IRLSSG-RS)
  • Time Frame: Week 6
    Safety Issue?: No
• 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)
  • Safety Issue?: No

Secondary Measures

• RLS quality-of-life questionnaire
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No
• Clinical Global Impression
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No
• Patient Global Impression
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No
• Sleep questionnaire form A
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No
• IRLSSG-RS
  • Time Frame: Week 30
    Safety Issue?: No
• Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram
  • Time Frame: Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2
    Safety Issue?: No
• Rating of severity of RLS at night (RLS-6 scale)
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No
• Rating of severity of RLS before bedtime (RLS-6 scale)
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No
• Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales)
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No
• Global rating of quality of sleep (RLS-6 scale)
  • Time Frame: Weeks 6 and 30
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00625547

Study ID Number: CABAS-0067-031

ClinicalTrials.gov Identifier: NCT00625547

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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