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      Randomised Clinical Efficacy Trial of Topiramate and Nitrazepam in Treatment of Infantile Spasms

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          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 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.

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          Most cited references31

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          A proposed diagnostic scheme for people with epileptic seizures and with epilepsy: report of the ILAE Task Force on Classification and Terminology.

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            Treatment and long term outcome in West syndrome: the clinical reality. A multicentre follow up study.

            We systematically reviewed the files of 51 infants presenting with infantile spasms and hypsarrhythmia in order to study the initial treatment strategies and the long term outcome. 80% of the infants were classified as symptomatic. In the nine participating centres, different treatment protocols were used, but the large majority of the children received vigabatrin as first line treatment. Second line options included hormonal treatment, topiramate and valproate. The time to reach cessation of infantile spasms was significantly shorter in the cryptogenic group than in the symptomatic group (50% at 13 days versus 66 days respectively) and was irrespective of the treatment used. The late follow up data (>2 years) showed that 60% of the children had epilepsy and that 75% of the children had a delay in their psychomotor development. Again, outcome in the cryptogenic group was better than in the symptomatic group, but also in the cryptogenic group, 50% of the children had a clear developmental delay, even if spasms were controlled early in the course of the disease. Our retrospective study illustrates that not only the underlying brain dysfunction is the major determinant for later outcome in infantile spasms (symptomatic group) but also even a short period of infantile spasms can be responsible for later developmental delay (cryptogenic group).
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              A retrospective study on aetiology based outcome of infantile spasms.

              The goal of this retrospective study is to review the causes of infantile spasms and to correlate aetiology with outcome. All children diagnosed with infantile spasms between 1990 and 2003 at our institution were included. Charts were reviewed for the presence or absence of a defined aetiology/association, response to treatment, long-term epileptic and cognitive outcome. 80 out of 95 children are included in this review. 50 children (63%) had symptomatic spasms with disorders of cortical development being the most frequent cause followed by neonatal injury and tuberous sclerosis. Symptomatic children with developmental brain lesions responded at a rate of 54% to vigabatrin versus 62% for ACTH/prednisone, while other symptomatic aetiologies 83% responded to vigabatrin versus 63% for ACTH/prednisone. Cryptogenic spasms responded at a similar rate to both drugs. Other than children with cryptogenic spasms, very few went on to develop normally. Our results are however biased by on average more than 30 days of delay to diagnosis. None of our children developed Lennox-Gastaut syndrome but a number developed severe epilepsy with multifocal spikes. The aetiology and prognosis of infantile spasms is evolving. To improve outcome, we need to reduce the delay to diagnosis and develop prospective double-blind randomized clinical trials looking at not only the epileptic outcome but also cognitive outcome of these children.
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                Author and article information

                Journal
                Iran J Child Neurol
                Iran J Child Neurol
                IJCN
                Iranian Journal of Child Neurology
                Shahid Beheshti University of Medical Sciences (Tehran, Iran )
                1735-4668
                1735-4668
                Winter 2014
                : 8
                : 1
                : 12-19
                Affiliations
                [1 ]Department of Pediatrics, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
                [2 ]Growth Disorders of Children Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran
                [3 ]Pediatrician
                Author notes
                Corresponding Author: Akhavan Karbasi S. MD Shahid Sadoughi Hospital, Ave Sina Blvd, Shahid Ghandi Blvd, Yazd, Iran Tel: +98 351 8224000-9, +98 9131519229 Fax: +98 351 8224100 Email: sakarbasi@yahoo.com
                Article
                IJCN-8-12
                3943058
                24665322
                2a10f51e-0ece-476f-b737-c8cbf8a597da
                2014: Iranian Journal of Child Neurology

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License, ( http://creativecommons.org/licenses/by/3.0/) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 2 January 2013
                : 2 March 2013
                : 28 April 2013
                Categories
                Original Article

                infantile spasms,topiramate,nitrazepam,seizure
                infantile spasms, topiramate, nitrazepam, seizure

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