drugset / Trial / NCT01364597
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
NaSingle-groupOpen-labelTreatment
Summary
This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.
Timeline
- Start
- 2011-08-01
- Primary completion
- 2022-02-03
- Completion
- 2022-02-03
Publications
- Results Lagae L, Klotz KA, Fogarasi A, Floricel F, Reichel C, Elshoff JP, Fleyshman S, Kang H. Long-term safety and efficacy of adjunctive brivaracetam in pediatric patients with epilepsy: An open-label, follow-up trial. Epilepsia. 2023 Nov;64(11):2934-2946. doi: 10.1111/epi.17754. Epub 2023 Sep 5.
- Results Bourikas D, Elmoufti S, Elshoff JP, Little A, Pucylowski K, Moseley B, Lagae L. Long-term tolerability and efficacy of adjunctive brivaracetam in pediatric patients with generalized-onset seizures: Subgroup analysis of an open-label, follow-up trial. Epilepsy Behav. 2025 Oct;171:110569. doi: 10.1016/j.yebeh.2025.110569. Epub 2025 Jul 29.
- Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brivaracetam | Small molecule | 5 mg/kg | Oral |
| Subject | Brivaracetam | Small molecule | 200 mg | Oral |