title: Randomised clinical efficacy trial of topiramate and nitrazepam in treatment of infantile spasms.
abstract: OBJECTIVE
  Infantile spasms (IS) are among the most catastrophic epileptic syndromes of infancy. The purpose of this study was to compare efficacy and safety of topiramate (TPM) and nitrazepam (NZP) as first-line drugs in the treatment of IS.
  
  
  METHODS
  In a parallel single-blinded randomized clinical trial, 50 patients with IS referred to Pediatric Neurology Clinic of Shahid Sadoughi University of Medical Sciences, Yazd, Iran, were evaluated from September 2008 to March 2010. Patients were randomly assigned to two groups to be treated with TPM or with NZP for 6 months. The primary endpoint was efficacy in cessation of all spasms or reduction of more than 50% in weekly seizure frequency, which was evaluated before and 6 months after the drug use. Secondary outcome was clinical sideeffects of the drugs.
  
  
  RESULTS
  Twenty boys (40%) and 30 girls (60%) with the mean age of 9.4±3.8 months were evaluated. Cessation of all spasms occurred in 12 (48%) infants in TPM group and 4(16%) in NZP group. Eight (32%) children in TPM group and 7 (28%) in NZP group had more than 50% reduction in spasms frequency. So, TPM was more effective. Side effects were seen in 32% of TPM and in 36% of NZP groups.
  
  
  CONCLUSIONS
  Topiramate is an effective and safe drug, which might be considered as the firstline drug for the treatment of ISs.
authors.affiliation: Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran ; Growth Disorders of Children Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
authors.forename: Razieh
authors.initials: R
authors.lastname: Fallah
authors.affiliation: Pediatrician.
authors.forename: Fahimah
authors.initials: F
authors.lastname: Salor
authors.affiliation: Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran ; Growth Disorders of Children Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
authors.forename: Sedighah
authors.initials: S
authors.lastname: Akhavan Karbasi
authors.affiliation: Pediatrician.
authors.forename: Hadi
authors.initials: H
authors.lastname: Motaghipisheh
keywords: Infantile spasms; Nitrazepam; Seizure; Topiramate