drugset / Trial / NCT00368251
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease (ULD) in Adolescents and Adults
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study will compare the efficacy and safety of Brivaracetam with placebo in patients with Unverricht- Lundborg Disease (ULD).
Timeline
- Start
- 2006-11
- Primary completion
- 2008-01
- Completion
- 2008-01
Outcome
Missed primary endpoint
registry analysis (unspecified test); Placebo vs Brivaracetam 150 mg/Day; p =0.942; Hodges-Lehmann-estimator of difference 0.15 (95% CI -26.12 to 24.96); NCT00368251 ↗
paper Estimated differences versus placebo were not statistically significant. PMID 26666500 ↗
Publications
- Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.
- Kalviainen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brivaracetam | Small molecule | 5 mg | Oral |
| Subject | Brivaracetam | Small molecule | 150 mg | Oral |