A Randomised, Double-blind, Placebo-controlled Dose Titration Trial With 0.125-0.75 mg Pramipexole (Sifrol®) Orally to Investigate the Safety and Efficacy in Out-patients With Idiopathic Restless Legs Syndrome for 6 Weeks Followed by 46 Weeks Open-label or Double-blind Treatment Period
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 346
- Locations
- 48
- Primary Endpoint
- Mean change from baseline to week 6 on the RLSRS +
Study Overview
Brief Summary
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week open label or double blind extension.
Detailed Description
To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks open label or double blind extension
Study Hypotheses:
Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from baseline and no difference in the CGI-I responder rates at the end of the 6 weeks double-blind treatment.
Comparison(s):
Pramipexole vs. Placebo
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Mean change from baseline to week 6 on the RLSRS +
CGI-I responders (much and very much improved)
Secondary Outcomes
- RLRS responders, CGI, PGI responders, EPSS, QoL (SF-36) VAS severity of RLS