Abstracts

Rationale: The aim of the present study was to compare the neuropsychological and behavioral outcome in children treated either with levetiracetam or sulthiame in benign epilepsy with centrotemporal spikes in a prospective, randomized double-blinded head to head study. Methods: 44 out of 89 screened patients were eligible for the study and randomly allocated to either sulthiame or levetiracetam treatment. Neuropsychological assessment was performed using the verbal learning and memory test (VLMT) and the Culture Fair Test (CFT) 1 and 20. Behavior was assessed with the Child Behavior Checklist (CBCL). The tests were performed prior to randomization and at the end of the observation period of 6 months. The study dosage was 6mg*kg and 30mg*kg for sulthiame and levetiracetam, respectively. Results: 43 out of 44 patients were available for final statistical analysis. One patient had to be excluded due to protocol violation. Seizure freedom was achieved in 81% of patients within the levetiracetam treatment group and in 91% within the sulthiame treatment group. Significant changes (p<0,05, two tailed significance) were observed in both treatment groups in total behavioral scores (CBLC) whereas changes in neuropsychological scores were less strong. Behavioral disturbances were the most common adverse event causing study termination. Conclusions: The rates of seizure free patients were high in both groups. Changes in CBCL scores indicate a significant impact on behavior patients treated either with levetiracetam or sulthiame.