Official Title: “A Double-Blind, Randomized, Placebo-Controlled Multicenter Efficacy Study 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 placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.

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 administered once daily in the evening: 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, followed by a stable dose for an additional 3 weeks
• Other: Placebo
  • Placebo oral tablets administered daily for 5 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Sleep efficiency
  • Time Frame: Week 5
    Safety Issue?: No
• PLMS-arousal index (PLMS-AI)
  • Time Frame: Week 5
    Safety Issue?: No

Secondary Measures

• Sleep Questionnaire Form A
  • Time Frame: Weeks 2 and 5
    Safety Issue?: No
• Quality of Life for RLS questionnaire
  • Time Frame: Weeks 2 and 5
    Safety Issue?: No
• Clinical Global Impressions
  • Time Frame: Weeks 2 and 5
    Safety Issue?: No
• Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography
  • Time Frame: Weeks 2 and 5
    Safety Issue?: No
• Total score of the severity rating scale of the International RLS (IRLS) Study Group
  • Time Frame: Weeks 2 and 5
    Safety Issue?: No
• RLS-6 severity scales
  • Time Frame: Weeks 2 and 5
    Safety Issue?: No

Inclusion Criteria:

• Idiopathic RLS
• Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4
• In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time

Exclusion Criteria:

• Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS

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 November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627003

Study ID Number: CABAS-0067-033

ClinicalTrials.gov Identifier: NCT00627003

Health Authority: Germany: Bundesinstitute fur Arzneimittel und Medicinprodukte

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Link to ClinicalStudyResults.org Posting