Restless Legs Syndrome
Conditions
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.
Interventions
DRUGPramipexole
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| RLSRS response (≥50% reduction from baseline in RLSRS) | at week 4, 6 and 12 |
| Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing) | week 12 |
| Change in routine laboratory tests | week 12 |
| Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination | 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 |
| Assessment of sudden onset of sleep (SOOS) | up to 93 days |
| Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing) | week 12 |
| CGI-I responder analysis | at week 4, 6 and 12 |
Countries
United States
Outcome results
None listed