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Pharmacokinetics, Efficacy, and Tolerability of Eslicarbazepine Acetate in Children and Adolescents With Epilepsy

From the Department of Research and Development, BIAL (Portela & Co, SA), S Mamede do Coronado, Portugal (Dr Almeida, Dr Nunes, Dr Soares-da-Silva); 4Health Limited, Cantanhede, Portugal (Dr Falcão); and Pediatric Neurology Clinic, Alexandru Obregia Hospital, Bucharest, Romania (Dr Minciu, Dr Butoianu, Dr Magureanu).

This study investigates the pharmacokinetics of eslicarbazepine acetate (ESL), a new voltage-gated sodium channel blocker, in epileptic children aged 2 to 7 years (n = 11) and 7 to 11 years (n = 8) and adolescents aged 12 to 17 years (n = 10). The study explores ESL efficacy and tolerability. Patients were treated with ESL once-daily doses of 5 mg/kg/day on weeks 1 to 4, 15 mg/kg/day on weeks 5 to 8, and 30 mg/kg/day (or 1800 mg/day, whichever was less) on weeks 9 to 12. At the end of each 4-week period, a 24-hour pharmacokinetic profiling was performed. Similar to adults, ESL was rapidly metabolized to eslicarbazepine. In all age groups, eslicarbazepine peak concentrations were reached 0.5 hour to 3 hours after ESL dosing, and C_max and AUC_0-24 were dose proportional. Eslicarbazepine C_max was similar between age groups following administration of identical ESL dose/kg, but AUC_0-24 depended on age due to a faster plasma clearance of eslicarbazepine in younger children compared with adolescents. R-licarbazepine and oxcarbazepine were minor metabolites. A dose-dependent decrease in seizure frequency was observed in children aged 2 to 7 years and adolescents aged 12 to 17 years but not in children aged 7 to 11 years. One patient in each group became seizure free. ESL was generally well tolerated.

Key Words: Eslicarbazepine acetate • children • adolescents • epilepsy • pharmacokinetics

Address for reprints: Professor Patricio Soares-da-Silva, Department of Research and Development, BIAL, À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal; e-mail: psoares.silva{at}bial.com.