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PUBLIC SUMMARY OF POSITIVE OPINION FOR ORPHAN DESIGNATION OF stiripentol for the treatment of severe myoclonic epilepsy in infancy European Public Assement Report New Drugs Approved in FY 2012,Pharmaceuticals and Medical Devices Agency Japan Summary Basis of Decision, Health Canada Chiron, C., Marchand, M. C., Tran, A., Rey, E., D’ Athis, P., Vincent, J., … Pons, G. (2000). Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial . STICLO study group. Lancet, 356(9242), 1638–1642. DIACOMIT® Summary of Product Characteristic, January 2014 BIOCODEX Dravet Syndrome/ Tonic-clonic seizures?
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DIACOMIT® Summary of Product Characteristic, January 2014 BIOCODEX PUBLIC SUMMARY OF POSITIVE OPINION FOR ORPHAN DESIGNATION of stiripentol for the treatment of severe myoclonic epilepsy in infancy European Public Assement Report New Drugs Approved in FY 2012,Pharmaceuticals and Medical Devices Agency Japan Summary Basis of Decision, Health Canada Quilichini, P. P., Chiron, C., Ben-Ari, Y., & Gozlan, H. (2006). Stiripentol, a putative antiepileptic drug, enhances the duration of opening of GABA-A receptor channels . Epilepsia, 47(4), 704–716. Thanh, T. N., Chiron, C., Dellatolas, G., Rey, E., Pons, G., Vincent, J., & Dulac, O. (2002). [Long-term efficacy and tolerance of stiripentaol in severe myoclonic epilepsy of infancy (Dravet’s syndrome)]. Archives de pédiatrie: organe officiel de la Sociéte française de pédiatrie , 9(11), 1120–1127. Chiron, C., Marchand, M. C., Tran, A., Rey, E., D’ Athis, P., Vincent, J., … Pons, G. (2000). Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial . STICLO study group. Lancet, 356(9242), 1638–1642. STICLO ITALY: data on file Fisher, J. L. (2009). The anti-convulsant stiripentol acts directly on the GABA(A) receptor as a positive allosteric modulator. Neuropharmacology, 56(1), 190–197. Fisher, J. L. (2011). Interactions between modulators of the GABA(A) receptor: Stiripentol and benzodiazepines. European journal of pharmacology , 654(2), 160–165. Giraud, C., Treluyer, J.-M., Rey, E., Chiron, C., Vincent, J., Pons, G., & Tran, A. (2006). In vitro and in vivo inhibitory effect of stiripentol on clobazam metabolism. Drug metabolism and disposition: the biological fate of chemicals , 34(4), 608–611. Grosenbaugh, D. K., & Mott, D. D. (2013). Stiripentol is anticonvulsant by potentiating GABAergic transmission in a model of benzodiazepine-refractory status epilepticus . Neuropharmacology, 67, 136–143. Plosker, G. L. (2012). Stiripentol : in severe myoclonic epilepsy of infancy (dravet syndrome) . CNS drugs, 26(11), 993–1001. LUSZCZKI 2006 Characterization of the Anticonvulsant, Behavioural and Pharmacokinetic Interaction Profiles of Stiripentol in Combination with Clonazepam, Ethosuximide, Phenobarbital, and Valproate Using Isobolographic Analysis . Epilepsia 2006 Nov;47(11):1841-54. Luszczki JJ, Ratnaraj N, Patsalos PN, Czuczwar SJ. FARWELL 1993 Stiripentol in atypical seizures in children an open trial . Epilepsia. 1993 Mar-Apr;34(2):305-11. Farwell JR, Anderson GD, Kerr BM, Tor JA, Levy RH Bialer, M., Johannessen, S. I., Kupferberg, H. J., Levy, R. H., Perucca, E., & Tomson, T. (2007). Progress report on new antiepileptic drugs: a summary of the Eigth Eilat Conference (EILAT VIII) . Epilepsy research, 73(1), 1–52.:10.1016/j.eplepsyres.2006.10.008 Cazali, N., Tran, A., Treluyer, J. M., Rey, E., D’ Athis, P., Vincent, J., & Pons, G. (2003). 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Characterization of the anticonvulsant, behavioral and pharmacokinetic interaction profiles of stiripentol in combination with clonazepam, ethosuximide, phenobarbital, and valproate using isobolographic analysis . Epilepsia, 47(11), 1841–1854. :10.1111/j.1528-1167.2006.00825.x Mesnil, M., Testa, B., & Jenner, P. (1988a). In vitro inhibition by stiripentol of rat brain cytochrome P-450-mediated naphthalene hydroxylation . Xenobiotica; the fate of foreign compounds in biological systems, 18(9), 1097–1106:10.3109/00498258809042232 Mesnil, M., Testa, B., & Jenner, P. (1988b). Ex vivo inhibition of rat brain cytochrome P-450 activity by stiripentol . Biochemical pharmacology, 37(19), 3619–3622. Perez, J., Chiron, C., Musial, C., Rey, E., Blehaut, H., D’ Athis, P., … Dulac, O. (1999). Stiripentol: efficacy and tolerability in children with epilepsy . Epilepsia, 40(11), 1618–1626. Poisson, M., Huguet, F., Savattier, A., Bakri-Logeais, F., & Narcisse, G. (1984). 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(1996). Effect of stiripentol on carbamazepine plasma concentration and metabolism in epileptic children. European journal of clinical pharmacology , 50(6), 497–500. Trojnar, M. K., Wojtal, K., Trojnar, M. P., & Czuczwar, S. J. (2005). Stiripentol. A novel antiepileptic drug . Pharmacological reports: PR, 57(2), 154–160. Wegmann, R., Ilies, A., & Aurousseau, M. (1978). [Pharmaco-cellular enzymology of the mechanism of action of stiripentol in cardiazol-induced epilepsy. II. Glucose metabolism]. Cellular and molecular biology, including cyto-enzymology, 23(4), 437–453. Using DIACOMIT®
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