A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

Last updated: April 22, 2011
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Williams Syndrome

Manic Disorders

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT00627003
CABAS-0067-033
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Idiopathic RLS

  • Moderate to severe symptoms as indicated by an IRLS total score greater than or equalto 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 duringsleep arousal index greater than 5/hour of total sleep time

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 43
Study Start date:
November 01, 2002
Estimated Completion Date:
May 31, 2003