N/A
Completed N=571
Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome
Source: ClinicalTrials.gov NCT01174459 ↗Enrolled (actual)
571
Serious AEs
2.0%
Results posted
Aug 2014
Primary outcomePrimary: Incidence of Drug-related Adverse Events — 76 participants
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.
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 | — |
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. Informational only — not medical advice.