Last updated: April 22, 2011
Sponsor: Pfizer
Overall Status: Completed
Phase
3
Condition
Williams Syndrome
Manic Disorders
Dyskinesias
Treatment
N/AClinical Study ID
NCT00627003
CABAS-0067-033
Ages 18-75 All Genders
Study Summary
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