Abstracts

Rationale: We conducted a prospective multicenter open label trial to evaluate the effectiveness of oxcarbazepine oral suspension (OXC) for newly diagnosed partial epilepsy patients in children.Methods: Children between the ages of 4-16 were eligible for the study if they had been diagnosed with partial epilepsy and experienced two or more partial-onset or generalized tonic-clonic seizures during the preceding 6 months. OXC was introduced as monotherapy to previously untreated children and was titrated over 2-4 weeks to effective target doses, followed by maintenance phase for another 24 weeks. The outcome measures were the seizure-free rate over 6 months and the change in cognition and behavior from screening to the end of the maintenance phase. Effectiveness of OXC was compared in intellectually normal versus impaired children (IQ<70).Results: We enrolled 171 patients (mean age, 9.2 2.7) including 99 boys and 72 girls. Maintenance dose of OXC was 24.9 8.0 mg/kg/day. Out of the 171 patients enrolled, 122 completed the study and 91 patients (53.2%) became seizure-free after using the OXC treatment. In comparing the efficacy of OXC for intellectually normal and impaired patients, 76 (53.5%) of 142 intellectually normal patients and 15 (51.7%) of 29 intellectually impaired patients became seizure-free (P=0.779). After treatment, the perceptual organization, picture completion, and attention and concentration subtests were improved in intellectually normal patients (P < 0.05), but no significant difference was seen between intellectually normal and impaired children. Adverse effects were reported in 56 (32.7%) of the patients and the drug was interrupted due to rashes in 16 (9.4%) cases. In comparing the adverse effects of OXC in intellectually normal and impaired patients, 46 (32.4%) of 142 intellectually normal patients and 9 (31.0%) of 29 intellectually impaired patients had adverse effects (P=0.677). Conclusions: Oxcarbazepine oral suspension is effective and well tolerated as monotherapy in children with partial epilepsy. There is no difference of the effectiveness and the adverse effects between intellectually normal and intellectually impaired children.