Sulthiame as monotherapy in children with benign childhood epilepsy with centrotemporal spikes: A 6-month randomized, double-blind, placebo-controlled study

Purpose: To evaluate the efficacy and tolerability of sulthiame (STM) as monotherapy in children with benign childhood epilepsy with centrotemporal spikes (BECTS). Methods: Sixty-six BECTS patients entered a 6-month double-blind trial and were randomized to receive either STM (5 mg/kg/day) or a placebo. All patients had had two or more seizures during the 6 months preceding the trial and were aged 3-11 years. Seizures were recorded by parents in a diary. STM plasma levels and electroencephaloprams (EEGs) were overseen by patient-blinded observers. The primary effectiveness variable was the rate of treatment failure events (TFEs) per group. TFEs consisted of a first seizure after a 7-day run-in period, intolerable adverse events (AEs), development of another epileptic syndrome, or termination of the trial by parents or patient. Results: Twenty-five of the 31 STM-treated patients (81%) and 10 of the 35 placebo-treated patients (29%) completed the trial without any TFEs (p = 0.00002). Most TFEs were seizures (n = 4 for the STM patients, n = 21 for the placebo group). Parents requested termination for two placebo-treated patients. Four patients were terminated for administrative reasons. No patient was withdrawn for AEs. While all patients displayed at least one specific focus in either the awake or asleep EEG initially, 11 STM-treated patients had a normal awake EEG and 10 had a normal asleep one after 6 months. Conclusions: STM was remarkably effective in preventing seizures in patients with BECTS. Patients suffering from greater than or equal to 2 seizures during the past 6 months had a high risk of early recidivism. STM was well tolerated and should be considered for children with BECTS who are in need of treatment.