drugset / Trial / NCT00504881
Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will compare the safety and efficacy of Brivaracetam at flexible dose with Placebo in subjects suffering from Epilepsy.
Timeline
- Start
- 2007-10
- Primary completion
- 2008-11
- Completion
- 2008-12
Publications
- Results Kwan P, Trinka E, Van Paesschen W, Rektor I, Johnson ME, Lu S. Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial. Epilepsia. 2014 Jan;55(1):38-46. doi: 10.1111/epi.12391. Epub 2013 Oct 3.
- Results Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.
- Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brivaracetam | Small molecule | 20 mg | Oral |
| Subject | Brivaracetam | Small molecule | 50 mg | Oral |
| Subject | Brivaracetam | Small molecule | 100 mg | Oral |
| Subject | Brivaracetam | Small molecule | 150 mg | Oral |