N/A
N=571
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Restless Legs Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01174459 ↗Enrolled (actual)
571
Serious AEs
2.0%
Results posted
Aug 2014
Primary outcome: Primary: Incidence of Drug-related Adverse Events — 76 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Drug-related Adverse Events |
76 | — |
| SECONDARY Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS) |
-13.42 | — |
Summary
The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.
Eligibility Criteria
Inclusion criteria
Patient with Restless Legs Syndrome
Exclusion criteria
None
Data sourced from ClinicalTrials.gov (NCT01174459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.