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• W1497448097 abstract "Stiripentol, a new antiepileptic drug inhibiting cytochrome P450-enzymes, suggested some efficacy when combined with carbamazepine in an open trial in refractory partial epilepsy of childhood. Our objective was to test these results in a placebo-controlled trial. To limit the number of patients included, we used an enrichment and withdrawal design. Among the 67 children entered in a 4-month open add-on stiripentol study following a 1-month single-blind placebo baseline, the 32 responders were randomized for 2 months either to continue stiripentol ( n = 17) or to withdraw to placebo ( n = 15). If seizures increased by at least 50% after randomization compared with baseline, the patients dropped out (primary end point): there were six patients on stiripentol and eight patients on placebo (not significant). However, a decrease in seizure frequency compared with baseline (secondary end point) was greater on stiripentol (—75%) than on placebo (—22%) ( P< .025). Twelve patients experienced at least one adverse event on stiripentol (71%) compared with four patients on placebo (27%); none were reported as severe. The combination of stiripentol and carbamazepine proved to reduce seizure frequency in children with refractory partial epilepsy, although it failed to show a significant impact according to the escape criteria selected as the primary end point in the present study, for ethical reasons. ( J Child Neurol 2006; 21: 496—502;" @default.
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• W1497448097 date "2006-06-01" @default.
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• W1497448097 title "Stiripentol in Childhood Partial Epilepsy: Randomized Placebo-Controlled Trial with Enrichment and Withdrawal Design" @default.
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• W1497448097 doi "https://doi.org/10.1177/08830738060210062101" @default.
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