A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
- Registration Number
- NCT00627003
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Cabergoline - 2 Placebo -
- Primary Outcome Measures
Name Time Method Sleep efficiency Week 5 PLMS-arousal index (PLMS-AI) Week 5
- Secondary Outcome Measures
Name Time Method RLS-6 severity scales Weeks 2 and 5 Sleep Questionnaire Form A Weeks 2 and 5 Quality of Life for RLS questionnaire Weeks 2 and 5 Clinical Global Impressions Weeks 2 and 5 Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography Weeks 2 and 5 Total score of the severity rating scale of the International RLS (IRLS) Study Group Weeks 2 and 5