Long-Term Use of Oxcarbazepine Oral Suspension in Childhood Epilepsy: Open-Label Study

Abstract

Studies designed specifically for the pediatric population are needed to assess the tolerability and safety of the new antiepileptic drugs. The purpose of this study was to document the safety, ease of dosing, and acceptance of oxcarbazepine oral suspension in pediatric patients in monotherapy and polytherapy. A prospective, multicenter, open-label study was conducted at the neurology services of three pediatric university hospitals over 12 months. After obtaining signed informed consent, we enrolled a series of 62 patients with epilepsy aged between 2 months and 14 years who began oxcarbazepine treatment in monotherapy or in combination with other antiepileptic drugs to assess the seizure frequency, safety (adverse events), and acceptance of the pharmaceutical form by the patient's family. Fifty patients (80.6%) reduced seizures by at least 50%, 44 (71%) saw a reduction in seizure frequency of over 75%, and 29 (46.8%) were seizure free at the end of the study. The difference in the number of seizures before and after the study was statistically significant, both overall and by type of pathology. Adverse events occurred in four patients (6.4%) and required withdrawal of the drug in two cases (skin rash); three patients (4.8%) withdrew for inefficacy. Five patients (8.1%) withdrew from the treatment. We concluded that, in this series of patients, oxcarbazepine in oral suspension form was seen to help reduce seizure frequency, to have few side effects, and to be accepted by parents and patients. (J Child Neurol 2006;21:480—485; DOI 10.2310/7010.2006.00120).

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References

Gilman JT , Duchowny M. , Campo AE : Pharmacokinetic considerations in the treatment of childhood epilepsy. Pediatr Drugs 2003;5:267—277.

French JA , Kanner AM , Bautista J. , et al: Efficacy and tolerability of the new antiepileptic drugs II: Treatment of refractory epilepsy: Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2004; 62: 1261—1273.

French JA , Kanner AM , Bautista J. , et al: Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new onset epilepsy: Report of the Therapeutics and Technology Assessment Subcommittee and Quality Standards Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2004; 62:1252-1260

Serdaroglu G. , Kurul S. , Tutuncuoglu S. , et al: Oxcarbazepine in the treatment of childhood epilepsy. Pediatr Neurol 2003;28:37—41.

Beydoun A. : Monotherapy trials of new antiepileptic drugs. Epilepsia 1997;38(Suppl):21—31.

Sabers A. , Moller A. , Dam M. , et al: Cognitive function and anticonvulsant therapy: Effect of monotherapy in epilepsy. Acta Neurol Scand 1995;92:19—27.

Bang LM , Karen LG : Oxcarbazepine: A review of its use in children with epilepsy. Pediatr Drugs 2003;5:557—573.

Tecoma ES : Oxcarbazepine. Epilepsia 1990;40(Suppl 5):S37—S46.

Walmil AW , Schmutz M. , Porte C. , et al: Effects of oxcarbazepine and 10-hydroxycarbamazepine on action potential firing and generalized seizures. Eur J Pharmacol 1994;271:301—308.

10.

Ichikawa K. , Koyama N. , Kiguchi S. , et al: Inhibitory effect of oxcarbazepine on high-frequency firing in peripheral nerve fibres. Eur J Pharmacol 2001;420:119—192.

11.

Stefani A. , Pisan A. , De Murtras M. , et al: Action of GP 47779, the active metabolite of oxcarbazepine on the corticostriatal system II: Modulation of high-voltage-activated calcium currents. Epilepsia 1995;36:997—1002.

12.

Pariente-Khayat A. , Tran A. , Vauzelle-Kervuroedan F. , et al: Pharmacokinetic of oxcarbazepine as add-on therapy in epileptic children, abstract. Epilepsia 1994;35(Suppl 8):119.