Levetiracetam vs. sulthiame in benign epilepsy with centrotemporal spikes in childhood: AÂ double-blinded, randomized, controlled trial (German HEAD Study)

The study results concerning non-inferiority were not conclusive, as the calculated sample size was not reached to support sufficient statistical power due to limited recruitment in a 26 months period. The rates of seizure free patients were [relatively] 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.