Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
- Conditions
- Restless Legs Syndrome
- Registration Number
- NCT00133198
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 345
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change from baseline in the total score of RLSRS (Restless Legs Syndrome rating scale for severity) of the IRLSSG (International Restless Legs Syndrome Study Group) week 12 CGI-I (CGI-Improvement) week 12
- Secondary Outcome Measures
Name Time Method CGI-I responder analysis at week 4, 6 and 12 Change from baseline in CGI-Severity at week 4, 6 and 12 CGI-therapeutic effect at week 4, 6 and 12 CGI-Side effects at week 4, 6 and 12 Patient Global Impression (PGI) at week 1-4, 6 and 12 RLSRS response (≥50% reduction from baseline in RLSRS) at week 4, 6 and 12 Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination week 12 Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep at week 4, 6 and 12 Change from baseline in Epworth sleepiness scale (ESS) at week 4, 6 and 12 Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire) at week 6 and 12 Change from baseline in Augmentation Severity Rating Scale of IRLSSG at week 6 and 12 Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing) week 12 Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing) week 12 Assessment of sudden onset of sleep (SOOS) up to 93 days Change in routine laboratory tests week 12 Change in Electrocardiogram 12 weeks Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms) up to 93 days Concomitant medication reporting 12 weeks Early withdrawal phenomena 12 weeks
Trial Locations
- Locations (42)
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Mayo Clinic - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Boehringer Ingelheim Investigational Site
🇺🇸Columbia, South Carolina, United States
HealthQuest Clinical Trials Research
🇺🇸San Diego, California, United States
Stanford Sleep Clinic
🇺🇸Stanford, California, United States
Adult CF Center
🇺🇸Denver, Colorado, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
CNI Movement Disorders Center
🇺🇸Englewood, Colorado, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Scroll for more (32 remaining)Pivotal Research Centers🇺🇸Peoria, Arizona, United States