randomised clinical efficacy trial of topiramate and nitrazepam in treatment of infantile spasms

how to cite this article:  fallah r, salor f, akhavan karbasi s, motaghipisheh h. randomised clinical efficacy trial of topiramate and nitrazepam in treatment of infantile spasms. iran j child neurol. 2014 winter; 8(1):12-19. 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. materials & 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. conclusion topiramate is an effective and safe drug, which might be considered as the firstline drug for the treatment of iss. references: watemberg n. infantile spasms: treatment challenges. curr treat options neurol 2012;14(4):322-31. tsao cy. current trends in the treatment of infantile spasms. neuropsychiatr dis treat 2009;5:289-99. sankar r, koh s, wu j, menkes jh. paroxysmal disorders. in: menkes jh, sarnat hb, maria bl, editors child neurology,7th ed. philadelphia: lippincott; 2006.p. 877. engel j jr. international league against epilepsy (ilae). a proposed diagnostic scheme for people with epileptic seizures and with epilepsy: a report of the ilea task force on classification and terminology. epilepsia 2001; 42(6):796–803. riikonen rs. favourable prognostic factors with infantile spasms. eur j paediatr neurol 2010;14(1):13-18. lagae l, verhelst h, ceulemans b, de meirleir l, nassogne mc, de borchgrave v, et al. treatment and long term outcome in west syndrome: the clinical reality. a multicentre follow up study. seizure 2010;19(3):159-64. fois a. infantile spasms: review of the literature and personal experience. ital j pediatr 2010;36:15-21. jaseja h. justification of vigabatrin administration in west syndrome patients? 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