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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
345
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)
Time frame: week 12
CGI-I (CGI-Improvement)
Time frame: week 12
RLSRS response (≥50% reduction from baseline in RLSRS)
Time frame: at week 4, 6 and 12
CGI-I responder analysis
Time frame: at week 4, 6 and 12
Change from baseline in CGI-Severity
Time frame: at week 4, 6 and 12
CGI-therapeutic effect
Time frame: at week 4, 6 and 12
CGI-Side effects
Time frame: at week 4, 6 and 12
Patient Global Impression (PGI)
Time frame: at week 1-4, 6 and 12
Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep
Time frame: at week 4, 6 and 12
Change from baseline in Epworth sleepiness scale (ESS)
Time frame: at week 4, 6 and 12
Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire)
Time frame: at week 6 and 12
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Pivotal Research Centers
Peoria, Arizona, United States
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States
Boehringer Ingelheim Investigational Site
Fountain Valley, California, 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 D.C., District of Columbia, United States
PAB Clinical Research
Brandon, Florida, United States
...and 34 more locations
Change from baseline in Augmentation Severity Rating Scale of IRLSSG
Time frame: at week 6 and 12
Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing)
Time frame: week 12
Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing)
Time frame: week 12
Change in routine laboratory tests
Time frame: week 12
Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination
Time frame: week 12
Change in Electrocardiogram
Time frame: 12 weeks
Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms)
Time frame: up to 93 days
Concomitant medication reporting
Time frame: 12 weeks
Early withdrawal phenomena
Time frame: 12 weeks
Assessment of sudden onset of sleep (SOOS)
Time frame: up to 93 days