The Influence of Sulthiame on EEG in Children with Benign Childhood Epilepsy with Centrotemporal Spikes (BECTS)

Abstract

Summary:Purpose: To evaluate the effects of sulthiame (Ospolot; STM) monotherapy compared with placebo on the EEG in children with benign childhood epilepsy with centrotemporal spikes (BECTS).Methods: Sixty-six patients (aged 3-11 years) entered a 6-month double-blind trial and were randomized to either STM (n ‫ס‬ 31) or placebo (n ‫ס‬ 35). Clinical data and general results have been reported elsewhere (1). One-hundred seventy-nine sleep EEGs were recorded at screening and after 4 weeks, 3 months, and 6 months. EEGs were analyzed by a blind reviewer using a standard protocol for each EEG. This standard protocol collected data on general changes, specific epileptiform, and nonspecific focal and generalized changes. A classification system was defined depending on rating of pathologic EEG changes. Because of the higher number of treatment-failure events (i.e., seizures) in the placebo group, there was an increasing imbalance between the two groups regarding the number of recorded sleep EEGs over time (STM, 104; placebo, 74). A Wilcoxon-Mann-Whitney U test was used to describe differences in the grade of pathology during individual follow-up between the two groups.Results: The sleep-EEG was found to be normalized in 21 patients treated with STM (12/21 transient) and in five patients treated with placebo (4/5 transient). In the STM group, the EEG showed a marked improvement during intraindividual course when comparing the classification of follow-up EEGs at each time point with the screening EEG. Comparable improvements were not observed in the placebo group (exact two-tailed p value at 4 weeks, p < 0.0001; at 3 months, p ‫ס‬ 0.0010; and at 6 months, p < 0.0001).Conclusions: STM had marked effects on the EEG in BECTS, which led to normalization in the majority of the patients. Most of those whose EEGs were not normalized showed improvement in the grade of EEG pathology. Normalization persisted in >50% of patients during the investigation. Spontaneous normalization in the placebo group reflects the wide spectrum of individual courses, which must be considered when analyzing drug effects on EEG in BECTS.

Benign Childhood Epilepsy with Centrotemporal Spikes: To Treat or Not to Treat

“…In addition, the spike rate increased in the treatment group and decreased in the non-treatment group after 6 months; however, this difference was not statistically significant. These findings are not in agreement with previous studies 17,18. Again, this likely occurred because of the small sample size and low dose of OXC used during the study period.…”

Antiepileptic drug treatment in children

“…Many AEDs were reported efficacious, including OXC and CZP [103,104]. However, randomized trials have been performed with only GBP and sulthiame [50,30]; the latter was also recently reported to normalize the EEG [105].…”

Spike Morphology, Location, and Frequency in Benign Epilepsy With Centrotemporal Spikes

“…Bast et al evaluated the effect of sulthiame on the EEG of children with benign epilepsy with centrotemporal spikes. 23 In the placebo group of that study, 5 of 35 patients demonstrated spontaneous normalization of the EEG over 6 months. In our study, only 8 patients, not on medication, had follow-up recordings.…”