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Abstract
Objective: To evaluate the efficacy, safety, and pharmacokinetics of oxcarbazepine as adjunctive therapy in infants and young children (1 month to <4 years).
Methods: Children 1 month to <4 years of age with inadequately controlled partial seizures taking up to two concomitant antiepileptic drugs (AEDs) were enrolled in this rater-blind, randomized, parallel-group study. Patients received either high-dose (60 mg/kg/day) or low-dose (10 mg/kg/day) oxcarbazepine as oral suspension. The primary efficacy variable was the absolute change in electrographic partial seizures with a behavioral correlate (type 1 seizure) frequency per 24 hours during the last 72 hours of continuous video-EEG monitoring in the treatment phase compared with baseline seizure frequency.
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.
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