A randomized controlled trial of flunarizine as add-on therapy and effect on cognitive outcome in children with infantile spasms.

摘要: Summary Purpose:  Cognitive impairment is observed commonly in children with a history of infantile spasms (IS). The goal this study was to prospectively examine the effect on cognitive outcome neuroprotective agent used as adjunctive therapy during treatment spasms. Methods:  In randomized controlled trial, patients received standardized plus flunarizine or placebo. consisted vigabatrin first-line therapy. Nonresponders were switched intramuscular synthetic adrenocorticotropic hormone (sACTH depot) after 2 weeks and, if necessary, topiramate two additional weeks. Vineland Adaptive Behavior Scale (VABS) and Bayley Scales Infant Development (BSID) measures 24 months intervention. Key Findings:  Sixty-eight 101 diagnosed over 3 years seven centers Canada either Sixty-five 68 (96%) became spasm-free within 8 weeks no late relapse occurred. results available at baseline 24 months 45 children. There significant difference BSID developmental quotient between flunarizine- placebo-treated (44.3 ± 35.5 vs. 30.9 ± 29.8; p = 0.18) later (56.9 ± 33.3 46 ± 34.2; p = 0.29). However, 10 flunarizine-treated identified etiology had better than eight controls both (84.1 ± 11.3 72.3 ± 9.8; p = 0.03) (87.6 ± 14.7 69.9 ± 25.3; p = 0.07). Significance:  Our failed demonstrate protective cohort IS. An analysis subgroups suggested that may further improve etiology.