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[Efficacy and safety of the monotherapy with trileptal (oxcarbazepine) in children and adolescents.]

Author(s): Belousova ED, Mukhin KI, Ermolenko NA, Guzeva VI, Tysiachina MD, Mironov MB, Petrukhin AS

Affiliation(s): Moskovskii NII pediatrii i detskoi khirurgii, Moskva.

Publication date & source: 2010, Zh Nevrol Psikhiatr Im S S Korsakova., 110(5):45-50.

A prospective non-randomized non-controlled multicenter trial has been conducted. The trial included 254 children, aged from 11 months to 18 years (mean age 9,3+/-4,5 years), with predominantly focal forms of epilepsy treated with trileptal (oxcarbazepine). The observation period was 31 weeks. Efficacy and safety of therapy was assessed in 3 visits: screening and assignment to therapy (visit 1), the end of titration and achievement of maintenance dose (visit 2), assessment of maintenance therapy (visit 3). The percentage of patients with a positive response to the trileptal therapy (the decrease of seizure frequency by 50% and more) was 91,1%. The complete reduction of seizures was achieved in 59,4% of patients. Most of patients (95,3%) continued to receive trileptal until the end of the trial. The significant decrease (p<0,001) of seizure frequency from visit 1 to visit 3, the reduction of epileptiform activity (p<0,05) on the awake EEG in visit 3 were found. The mean effective dose of trileptal was 902,4 +/-442,7 mg/day, i.e. was less than 30 mg/kg/day, daily doses did not exceed 600 mg. Adverse effects were observed in 11,2% of patients but in 40% of cases they seemed not be related to the drug. The adverse effects were from mild to moderate extent. In conclusion, trileptal as the monotherapy is effective and well-tolerated in the treatment of focal epilepsies in the age groups studied.

Page last updated: 2010-10-05

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