Abstracts

Rationale: The aim of the present study was to compare the efficacy, tolerability and safety of levetiracetam and sulthiame in benign epilepsy with centrotemporal spikes in a prospective, randomized double-blinded head to head approach. Methods: 44 out of 89 screened patients were eligible for the study and randomly allocated to either sulthiame or levetiracetam treatment (for in- an exclusion criteria see table). Efficacy was defined as complete seizure remission during the observation period of 6 months. The dosage was 6mg*kg and 30mg*kg for sulthiame and levetiracetam, respectively. In addition, information of the occurrence of adverse events was collected. Results: 43 out of 44 patients were available for final statistical analysis. One patient had to be excluded due to protocol violation. Treatment failure events (=seizure recurrence) occurred in 4 patients (19.0%) in the levetiracetam (LEV) treatment group and in 2 patients (9.1%) in the sulthiame (STM) treatment group, respectively, (p=0.412, Fig. 1a). Study termination due to adverse reactions was higher in the LEV treatment group (n=5, 23.8%) than in STM treatment group (n=1, 4.5%, p=0.095, Fig. 1a). Serious adverse reactions occurred in patients treated with LEV (n=2, 9.5%, Fig. 1a). The total amount of dropouts due to either seizure recurrence or adverse events was significantly higher in the LEV group (n=9, 42.9%) compared to the STM group (n=3, 13.6%, p=0.030, Fig. 1b). Conclusions: The rates of seizure free patients were high in both groups. However, the results indicate that termination of drug treatment due to seizure recurrence or adverse events occurred more frequently in the LEV group compared to STM. Behavioral disturbances were the most common adverse event causing study termination.