PMID- 37336055 OWN - NLM STAT- MEDLINE DCOM- 20230804 LR - 20230804 IS - 1532-2688 (Electronic) IS - 1059-1311 (Linking) VI - 110 DP - 2023 Aug TI - Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (aged 4 to <12 years) with inadequately controlled focal-onset seizures: Japanese subgroup analysis. PG - 109-116 LID - S1059-1311(23)00157-7 [pii] LID - 10.1016/j.seizure.2023.06.004 [doi] AB - PURPOSE: To evaluate the safety and tolerability of adjunctive perampanel in a Japanese subpopulation of Study 311 (NCT02849626), which was a global, multicenter, open-label, single-arm study of children (aged 4 to <12 years) with inadequately controlled focal-onset seizures (FOS), with or without focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS). METHODS: Study 311 comprised a Core Study, Extension A, and Extension B; this report focuses on the Japanese patient subgroup in the Core Study only. In the Core Study, Japanese patients (FOS only) received adjunctive perampanel