This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Children with partial-onset seizures (POS) refractory to standard therapy remain a therapeutic challenge. New antiepileptic agents are need to effectively treat this patient population. Topiramate is a structurally unique compound that is effective and well-tolerated as an anticonvulsant after oral administration in animals and humans. It is approved and marketed worldwide as adjunctive treatment in adult and pediatric patients (2-16 yrs) with refractory POS. This is a worldwide, randomized, open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of topiramate used as adjunctive therapy in infants with refractory POS. The primary objective of this study is to determine the concentration-time profile for topiramate using a sparse sampling schedule, following topiramate administration at doses rangeing from 3-25 mg/kg/day, of either oral liquid or sprinkle capsure formulations in children aged 1-23 months with refractory POS taking 1 or 2 concomitant antiepileptic drugs. Information derived from this study will be utilized to define further dose recommendations in this age group.
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