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Stiripentol in Childhood Partial Epilepsy: Randomized Placebo-Controlled Trial with Enrichment and Withdrawal Design

Inserm, U663, Paris, F-75015, France, Neuropediatric Department, Hospital Necker-Enfants Malades, Paris, F-75015, chiron{at}nck.aphp.fr

Sylvie Tonnelier, PharmD

Department of Perinatal and Pediatric Pharmacology, Hospital Saint Vincent de Paul, Paris, France

Elisabeth Rey, PharmD

Department of Perinatal and Pediatric Pharmacology, Hospital Saint Vincent de Paul, Paris, France

Marie-Lucie Brunet, PharmD

Pharmacy Department, Montrouge, France

Agnes Tran, PharmD

Department of Perinatal and Pediatric Pharmacology, Hospital Saint Vincent de Paul, Paris, France

Philippe d'Athis, PhD

Department of Perinatal and Pediatric Pharmacology, Hospital Saint Vincent de Paul, Paris, France

Jean Vincent, PharmD

Biocodex, Montrouge, France

Olivier Dulac, MD

Inserm, U663, Paris, F-75015, France, Neuropediatric Department, Hospital Necker-Enfants Malades, Paris, F-75015

Gerard Pons, MD, PhD

Department of Perinatal and Pediatric Pharmacology, Hospital Saint Vincent de Paul, Paris, France

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;

Journal of Child Neurology, Vol. 21, No. 6, 496-502 (2006)
DOI: 10.1177/08830738060210062101


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