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. 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 side-effects 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 first-line drug for the treatment of ISs.