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)
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Mid America NeuroScience Institute
🇺🇸Lenexa, Kansas, United States
HealthQuest Clinical Trials Research
🇺🇸San Diego, California, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Henry Ford Hospital - Sleep Disorders and Research Center
🇺🇸Detroit, Michigan, United States
932 Morreene Road #264
🇺🇸Durham, North Carolina, United States
Attn: Dr. David Mayleben
🇺🇸Cincinnati, Ohio, United States
Attn: Controller/Grants & Contracts Accounting
🇺🇸Oklahoma City, Oklahoma, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Atlanta Pulmonary Group, LLC
🇺🇸Atlanta, Georgia, United States
Ohio Sleep Medicine Institute
🇺🇸Dublin, Ohio, United States
CNI Movement Disorders Center
🇺🇸Englewood, Colorado, United States
Cleveland Clinic Florida- Department of Neurology
🇺🇸Weston, Florida, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Sleep Disorders Center
🇺🇸Jackson, Mississippi, United States
University of Iowa Health Care
🇺🇸Iowa City, Iowa, United States
5671 Peachtree Dunwoody Road
🇺🇸Atlanta, Georgia, United States
Sleepmed, Inc
🇺🇸Macon, Georgia, United States
170 Thomas Johnson Dr, Suite 100
🇺🇸Frederick, Maryland, United States
Sleep Health Centers
🇺🇸Newton Center, Massachusetts, United States
Center for Sleep and Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Lovelace Scientific Resources
🇺🇸Albuquerque, New Mexico, United States
Center For Sleep Medicine
🇺🇸Lafayette Hill, Pennsylvania, United States
1500 N. Bearegard St, #300
🇺🇸Alexandria, Virginia, United States
Sleep Associates
🇺🇸Plano, Texas, United States
Mayo Clinic - Scottsdale
🇺🇸Scottsdale, Arizona, United States
Pivotal Research Centers
🇺🇸Peoria, Arizona, United States
Boehringer Ingelheim Investigational Site
🇺🇸Columbia, South Carolina, United States
Stanford Sleep Clinic
🇺🇸Stanford, California, United States
Adult CF Center
🇺🇸Denver, Colorado, United States
George Washington University Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
PAB Clinical Research
🇺🇸Brandon, Florida, United States
Broward Research Group
🇺🇸Pembroke Pines, Florida, United States
Clinical Research Group of St Petersburg
🇺🇸St.Petersburg, Florida, United States
Winthrop Sleep Disorders Center
🇺🇸Mineola, New York, United States
Wilmington Health Associates
🇺🇸Wilmington, North Carolina, United States
The Arthritis Group
🇺🇸Philadelphia, Pennsylvania, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Lynchburg Pulmonary Associates, Inc.
🇺🇸Lynchburg, Virginia, United States
Movement Disorders Clinic
🇺🇸Augusta, Georgia, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Sleep Medicine Center
🇺🇸St.Louis, Missouri, United States