Further members of the Sulthiame Study Group: (A) Investigators: D. Škarpa, N Barišić, and M. Jurin, University Children's Hospital, Zagreb; V. Sander, Tallinn Children's Hospital; C. Benninger and K, Schrader, University Children's Hospital, Heidelberg; H. Siemes and K.H. Spohr, Kinderklinik Pulsstraβe, Berlin; R. Knapp, Städt Klinikum, Braunschweig; P. Temin and M. Nikanorova, Institute of Paediatrics and Paediatric Surgery, Moscow; J.P. Ernst and P. Burkard, Epilepsiezentrum, Kehl-Kork; B. Kruse and B. Wilken, University Children's Hospital, Göttingen; M. Wolff, University Children's Hospital, Tübingen; M. Laub and G. Kluger, Behandlungszentrum, Vogtareuth; D. Hobusch and K. Popp, University Children's Hospital, Rostock; R. Korinthenberg, University Children's Hospital, Freiburg; M. Brozmanová and P. Sýkora, University Children's Hospital, Bratislava; B. Püst and D. Will, Kinderkrankenhaus Wilhelmstift, Hamburg; U. Stephani and B. Neubauer, University Children's Hospital, Kiel; O. Hasselmann, A. Conradi, and M. Meusers, Gemeinschaftskrankenhaus, Herdecke; M. Haupt, Kinderklinik Klinikum, Erfurt; M. Büsse and H.M/ Straβburg, University Children's Hospital, Würzburg; M. D'Hooghe, Algemeen Ziekenhuis St Jan, Brugge; G. Groβ-Selbeck and M. Kuhlenkampf, Krankenhaus, Düsseldorf-Gerresheim; J. Saracz, Heim Pál Gyermek Kórház, Budapest; G. Wohlrab, Kinderspital, Zürich; M. Brünger, Pfalzinstitut, Klingenmünster; M. Schächtele, Städt. Kinderklinik, Karlsruhe; H. Todt, University Children's Hospital, Dresden; K. Kellermann, K. Rheingans, Kinderkrankenhaus der Stadt, Köln; (B) Serum Level Observer, A. Retzow, Reinfeld; (C) Biometrician, A. Völp, Psy Consult Scientific Services, Frankfurt; (D) Steering Committee, H.M. Weinmann, Starnberg; R. Kruse, Kehl-Kork; C. Lipinski, Rehabilitionsklinik, Neckargemünd.
The Influence of Sulthiame on EEG in Children with Benign Childhood Epilepsy with Centrotemporal Spikes (BECTS)
Article first published online: 6 FEB 2003
Volume 44, Issue 2, pages 215–220, February 2003
How to Cite
Bast, T., Völp, A., Wolf, C. and For The Sulthiame Study Group, D. (2003), The Influence of Sulthiame on EEG in Children with Benign Childhood Epilepsy with Centrotemporal Spikes (BECTS). Epilepsia, 44: 215–220. doi: 10.1046/j.1528-1157.2003.51001.x
- Issue published online: 6 FEB 2003
- Article first published online: 6 FEB 2003
- Accepted September 16, 2002.
- Centrotemporal spikes;
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 = 31) or placebo (n = 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 = 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.