Topiramate as Migraine Prophylaxis in Pediatric Patients: An Integrated Summary of Randomized Controlled Trials

Abstract

Background: An integrated analysis of five randomized, placebo-controlled studies in migraine prophylaxis was conducted to assess topiramate’s efficacy and safety in pediatric patients. Methods: Study 1, a pivotal study (50-, 100 mg/day; aged 12-17 years), Study 2 (flexibly-dosed 2-3 mg/kg/day; aged 6-15 years), and Studies 3, 4 and 5 [50-, 100-, 200 mg/day; aged ≥ 12 years)]. Results: Percent reduction in the average monthly migraine attack rate: Study 1: the 100 mg/day group improved versus placebo (72% versus 44%, p=0.0164); Study 2: topiramate was not significantly different from placebo (58% versus 48%); Studies 3, 4 and 5: positive trend in the 100 mg/day group versus placebo (75% versus 37%). ≥ 50% reduction responder rate: Study 1 - the 100 mg/day group improved versus placebo (83% versus 45%, [p=0.0048]); no significant effect for topiramate versus placebo was seen in either Study 2 (56% versus 49%), or Studies 3, 4 and 5 (69% versus 33%). Most common treatment-emergent adverse events in topiramate group were influenza-like symptoms, language problems and paresthesia. Conclusion: Overall, topiramate was efficacious for migraine prophylaxis in adolescent patients (12-17 years). The most consistent results were observed with topiramate 100 mg/day dose, which was generally well-tolerated.