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Long-term Safety and Efficacy of Adjunctive Brivaracetam in Pediatric Patients with Epilepsy: an Open-label, Follow-up Trial

Lieven LagaeKerstin A. KlotzAndras FogarasiFlorin FloricelChristoph ReichelJan-Peer ElshoffSofia FleyshmanHarriet Kang

出版	Universität, 2023
URL	http://books.google.com.hk/books?id=_h9o0AEACAAJ&hl=&source=gbs_api

註釋Abstract: Objective
This study was undertaken to evaluate the long-term safety, tolerability, and efficacy of adjunctive brivaracetam (BRV) treatment in pediatric patients with epilepsy.

Methods
A phase 3, open-label, multicenter, long-term follow-up trial (N01266; NCT01364597) was conducted on patients (aged 1 month to 17 years at core trial entry; direct enrollers aged 4 to 17 years) treated with BRV. Outcomes included treatment-emergent adverse events (TEAEs), behavior assessments (Achenbach Child Behavior Checklist [CBCL], Behavior Rating Inventory of Executive Function [BRIEF]/BRIEF-Preschool version [BRIEF-P]), and efficacy outcomes (percent change in focal seizure frequency, 50% responder rate for all seizure types for patient subgroups 2 years and ≥2 years of age using daily record card data).brbrResultsbrOf 257 patients with ≥1 dose of BRV (141 [54.9%] male; mean age = 8.0 years [SD = 4.5]), 36 patients were