title: Levetiracetam vs. sulthiame in benign epilepsy with centrotemporal spikes in childhood: a double-blinded, randomized, controlled trial (German HEAD Study).
abstract: OBJECTIVE
  To show non-inferiority of levetiracetam to sulthiame with respect to efficacy, tolerability and safety in benign epilepsy with centrotemporal spikes in a prospective, double-blinded randomized controlled trial.
  
  
  METHODS
  A sample size of 60 subjects (treatment group) was calculated to show reliable statistical results for non-inferiority. A total of 44 patients could be randomly allocated to either (LEV or STM) treatment group. Explorative data analysis was performed to investigate differences in the number of treatment failure events (occurrence of a seizure during the observation period of 6 months) and total dropouts. In addition, information of the occurrence of adverse events was collected.
  
  
  RESULTS
  43 patients were analyzed. One patient had to be excluded due to protocol violation. Treatment failure events occurred in four patients (19.0%) in the LEV treatment group and in two patients (9.1%) in the STM treatment group, respectively, (p = 0.412). The number of dropouts due to adverse reactions was five in the LEV treatment group and one in STM treatment group (23.8% vs. 4.5%, respectively, p = 0.095). Severe adverse events occurred in patients treated with LEV (n = 2, 9.5%). The total number of dropouts due to either seizure recurrence or adverse events was significantly higher in the LEV group (n = 9, 42.9%) compared to the STM group (n = 3, 13.6%, p = 0.03).
  
  
  CONCLUSIONS
  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.
authors: Department of Pediatric Neurology and Developmental Medicine, University of Munich, Munich, Germany. ingo.borggraefe@med.uni-muenchen.de
authors: Ingo
authors: I
authors: Borggraefe
authors: Michaela
authors: M
authors: Bonfert
authors: Thomas
authors: T
authors: Bast
authors: Bernd Axel
authors: BA
authors: Neubauer
authors: Klaus Juergen
authors: KJ
authors: Schotten
authors: Kai
authors: K
authors: Maßmann
authors: Soheyl
authors: S
authors: Noachtar
authors: Ingrid
authors: I
authors: Tuxhorn
authors: Theodor W
authors: TW
authors: May
authors: Florian
authors: F
authors: Heinen
mesh_terms: D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D055502:Secondary Prevention; D013843:Thiazines / Q000009:adverse effects* / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome; D000096926:Benzenesulfonamides
chemical_list: D000927:Anticonvulsants; D000077287:Levetiracetam; D010889:Piracetam; D013843:Thiazines; C084593:sulthiame; D000096926:Benzenesulfonamides
keywords: BECTS; Levetiracetam; Sulthiame