Sulthiame as Monotherapy in Children with Benign Childhood Epilepsy with Centrotemporal Spikes: A 6-Month Randomized, Double-Blind, Placebo-Controlled Study

Authors

  • Dietz Rating,

    Corresponding author
    1. Department of Child Neurology, Kinderklinik, Ruprecht-Karls-Universilät, Heidelberg, Germany
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  • Christian Wolf,

    1. *Desitin Arzneimittel GmbH, Hamburg, Germany
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  • Thomas Bast

    1. Department of Child Neurology, Kinderklinik, Ruprecht-Karls-Universilät, Heidelberg, Germany
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    • 1

      Further Members of the Sulthiame Study Group: (A) Investigators: D škarpa, N Bariš and M. Turin, University Children's Hospital Zagreb–V Sander, Tallinn Children's Hospital–C Benninger and K Schrader, University Children's Hospital Heidelberg–H Siemes and KH Spohr, Kinderklinik Pulsstraße Berlin–R Knapp, Stadt. Klinikum Braunschweig–P Teminf and M Nikanorova, Institute of Paediatrics and Paediatric Surgery Moscow–JP 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 Prist 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 HM Straßburg, University Children's Hospital Würzburg–M D'Hooghe, Algemeen Ziekenhuis St Jan Brugge–G Groß-Selbeck and M Kuhlenkampf, Krankenhaus Düsseldorf-Gerresheim–J Saracz, Heim Pál Gyermek Kórház Budapest–G Wohlrab, Kinderspital Zurich–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, Desitin Arzneimittel GmbH Hamburg–(C) Biometrician: A Völp, psy consult Frankfurt–(D) Steering Committee: HM Weinmann, Starnberg–R Kruse, Kehl-Kork–C Lipinski, Rehabilitionsklinik Neckargemund.


Univ.-Kinderklinik, Abt. für Pädiatrische Neurologie, Im Neuenheimer Feld 150, D-69120 Heidelberg, Germany.

Summary

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 electroencephalograms (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 ≥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.

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