Oxcarbazepine adjunctive therapy in infants and young children with partial seizures

Objective: To evaluate the efficacy, safety, and pharmacokinetics of oxcarbazepine as adjunctive therapy in infants and young children (1 month to Methods: Children 1 month to Results: Of 191 patients screened, 128 were randomized: 64 to both oxcarbazepine dose groups. The median absolute change in type 1 seizure frequency per 24 hours was more effective for the high-dose group (−2.00) compared with the low-dose group (−1.37; p = 0.043). The median percentage reduction in type 1 seizure frequency per 24 hours was also greater in the high-dose group (83.33%) than in the low-dose group (46.18%; p = 0.047). The most frequent adverse events (≥10%) were somnolence and pyrexia, and most were mild in severity. Conclusions: In this study, high-dose oxcarbazepine was significantly more effective than low-dose oxcarbazepine in controlling partial seizures in infants and very young children.