title: Ineffectiveness of topiramate and levetiracetam in infantile spasms non-responsive to steroids. Open labeled randomized prospective study.
abstract: OBJECTIVE
  To compare the effectiveness of 2 novel antiepileptic drugs, topiramate and levetiracetam, as a second line treatment for infantile spasm when oral steroids fail.
  
  
  METHODS
  Forty infants under 2 years with clinically- and EEG-proven infantile spasms that did not respond to prednisone (2mg/kg/day in 2 divided doses) were recruited and randomized into 2 groups. They were randomly assigned to either topiramate (group 1; 1mg/kg/day for 3 days then increased by 1mg/kg/day every third day up to 6mg/kg/day) or levetiracetam (group 2; 10mg/kg/day for 5 days and then increased by 10mg/kg/day every 5 days up to 60mg/kg/day). The study was conducted in the Pediatric Neurology Department at the National Neuroscience Institute of King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia between January 2008 and December 2010.
  
  
  RESULTS
  Of the 20 patients included in the final data analysis, 11 (55%) were administered topiramate and 9 (45%) levetiracetam. Eighteen patients did not respond to the first drug, and subsequently to the other drug when crossed-over. Two patients with infantile spasm responded to either one drug without crossover. Their EEGs improved with time.
  
  
  CONCLUSIONS
  The present study demonstrated the ineffectiveness of topiramate and levetiracetam suggesting current treatment modalities are grossly inadequate underscoring the urgent need for more research efforts to overcome current deficiencies. Two patients with cryptogenic infantile spasm responded to treatment suggesting the potential for treatment of such patients with these 2 drugs, and merits further multicenter investigation.
authors.affiliation: Pediatric Neurology Department, National Neuroscience Institute, King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia. amahmoud2000@hotmail.com
authors.forename: Adel A
authors.initials: AA
authors.lastname: Mahmoud
authors.forename: Tamer M
authors.initials: TM
authors.lastname: Rizk
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Mansy
authors.forename: Jaffar A
authors.initials: JA
authors.lastname: Ali
authors.forename: Mohamad A
authors.initials: MA
authors.lastname: Al-Tannir
mesh_terms: D000927:Anticonvulsants / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005632:Fructose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D000077287:Levetiracetam; D008297:Male; D010889:Piracetam / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011241:Prednisone / Q000627:therapeutic use*; D011446:Prospective Studies; D019233:Retreatment; D013036:Spasms, Infantile / Q000188:drug therapy*; D000077236:Topiramate; D017211:Treatment Failure
chemical_list: D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose; D000077287:Levetiracetam; D011241:Prednisone; D010889:Piracetam