Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)
A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks
1 other identifier
interventional
345
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2004
Shorter than P25 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 23, 2005
CompletedNovember 8, 2013
November 1, 2013
10 months
August 22, 2005
November 7, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (19)
RLSRS response (≥50% reduction from baseline in RLSRS)
at week 4, 6 and 12
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
- +14 more secondary outcomes
Interventions
Sponsors & Collaborators
Study Sites (44)
Pivotal Research Centers
Peoria, Arizona, 85381, United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259, United States
Boehringer Ingelheim Investigational Site
Fountain Valley, California, 92708, United States
HealthQuest Clinical Trials Research
San Diego, California, 92123, United States
Stanford Sleep Clinic
Stanford, California, 94305-5730, United States
Adult CF Center
Denver, Colorado, 80206, United States
University of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
CNI Movement Disorders Center
Englewood, Colorado, 80113, United States
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
PAB Clinical Research
Brandon, Florida, 33511, United States
Broward Research Group
Pembroke Pines, Florida, 33026-1956, United States
Clinical Research Group of St Petersburg
St. Petersburg, Florida, 33707, United States
Cleveland Clinic Florida- Department of Neurology
Weston, Florida, 33331, United States
5671 Peachtree Dunwoody Road
Atlanta, Georgia, 30342, United States
Atlanta Pulmonary Group, LLC
Atlanta, Georgia, 30342, United States
Movement Disorders Clinic
Augusta, Georgia, 30912, United States
Sleepmed, Inc
Macon, Georgia, 31201, United States
University of Iowa Health Care
Iowa City, Iowa, 52242-1053, United States
Mid America NeuroScience Institute
Lenexa, Kansas, 66214, United States
Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana, 70808, United States
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815, United States
170 Thomas Johnson Dr, Suite 100
Frederick, Maryland, 21702, United States
Sleep Health Centers
Newton Center, Massachusetts, 02459, United States
Henry Ford Hospital - Sleep Disorders and Research Center
Detroit, Michigan, 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Sleep Disorders Center
Jackson, Mississippi, 39216, United States
Sleep Medicine Center
St Louis, Missouri, 63108, United States
Lovelace Scientific Resources
Albuquerque, New Mexico, 87108, United States
Winthrop Sleep Disorders Center
Mineola, New York, 11501, United States
932 Morreene Road #264
Durham, North Carolina, 27705, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Wilmington Health Associates
Wilmington, North Carolina, 28401, United States
Attn: Dr. David Mayleben
Cincinnati, Ohio, 45219, United States
Metrohealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017, United States
Attn: Controller/Grants & Contracts Accounting
Oklahoma City, Oklahoma, 73190-3046, United States
Center For Sleep Medicine
Lafayette Hill, Pennsylvania, 19444, United States
The Arthritis Group
Philadelphia, Pennsylvania, 19152, United States
Boehringer Ingelheim Investigational Site
Columbia, South Carolina, 29201, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Sleep Associates
Plano, Texas, 75093, United States
1500 N. Bearegard St, #300
Alexandria, Virginia, 22311, United States
Lynchburg Pulmonary Associates, Inc.
Lynchburg, Virginia, 24501, United States
Eastern Virginia Medical School
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
B.I. Pharmaceuticals,Inc./Ridgefield
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 23, 2005
Study Start
April 1, 2004
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
November 8, 2013
Record last verified: 2013-11