Open prospective study on oxcarbazepine monotherapy in children with epilepsy: a preliminary report.

none8PURPOSE: To evaluate the long-term efficacy, tolerability, and safety of oxcarbazepine (OXC) in children with epilepsy. METHODS: We enrolled 36 patients (median age 7.75) with new diagnosis of partial epilepsy in an open prospective study. All type of epilepsy were included: 25 patients were affected by idiopathic epilepsy, 8 by symptomatic epilepsy and three by cryptogenic epilepsy. Patients were then scheduled to come back for controls at three months (T1), 12 months (T2) and 24 months (T3) after the beginning of OXC-monotherapy (T0). At each control we evaluated patients through their seizure diary, a questionnaire on side effects, their level of 10-monohydroxy metabolite (MHD) and laboratory analysis. RESULTS: At T1, 21/36 patients (58.3%) were seizure-free, 3/36 patients (8.3%) showed an improvement higher than 50%, 3/36 (8.3%) lower than 50%, while 2/36 worsened (5.6%). In 7/36 (19.5%) patients, no improvement was reported. At T2 13/18 patients (72.2%) were seizure-free, 1/18 showed a response to therapy higher than 50% while 2/18 worsened (11%). In two patients no improvement was reported. A correspondence between MHD plasmatic levels and clinical response (r=0.49; p<0.05) was only registered at T1. An EEG normalization was observed in 25% of cases. Side effects were reported in 25% of cases, but symptoms progressively disappeared at follow-up. CONCLUSIONS: We can therefore conclude that OXC can be considered, for its efficacy and safety, as a first line drug in children with epilepsy.noneEmilio Franzoni; Caterina Garone; Jasenka Sarajlija; Stefano Gualandi; Elisabetta Malaspina; Ilaria Cecconi; Filomena Caterina Moscano; Valentina MarchianiEmilio Franzoni; Caterina Garone; Jasenka Sarajlija; Stefano Gualandi; Elisabetta Malaspina; Ilaria Cecconi; Filomena Caterina Moscano; Valentina Marchian