A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of topiramate for migraine prevention in pediatric subjects 12 to 17 years of age

Prophylaxis of Migraine in Children and Adolescents

“…Lewis et al [19] conducted a randomized, doubleblinded trial confirming the superiority of topiramate at a dose of 100 mg/day over placebo. Adolescents aged 12-17 years with a 6-month history of migraine were randomly assigned to receive 16 weeks of daily treatment with topiramate 50, 100 mg/day or placebo.…”

“…Topiramate at a dose of 50 mg/day failed to show superiority when compared with placebo. The most commonly reported adverse effects included upper respiratory tract infection, paresthesias, and dizziness [19]. In a placebo-controlled trial including 162 children aged 6-15 years, Winner et al [20] randomized patients to receive placebo or topiramate with a goal dose of 2 mg/kg/day.…”

Headache in Children and Adolescents

“…1,27,34À37 Anti-epileptics such as topiramate, 100 mg, have been shown to be effective for reduction of headache frequency, severity, and duration. 38,47,48 The most common side effects include cognitive impairment and weight loss. 1,34 Divalproate 15À45 mg/kg per day has demonstrated efficacy in reducing frequency as well as severity of pediatric migraine, with a 50% headache reduction seen.…”

Pediatric headache

“…The 50% responder rate was statistically significantly higher for the topiramate 100 mg/day treatment group compared with placebo (P ¼ 0.002). Topiramate 100 mg/day for preventive treatment of migraine was both effective and well tolerated in pediatric patients with migraine [52].…”

“…[52] recently completed a randomized, double-blinded, placebo-controlled, multicenter, 16-week study to evaluate the efficacy and safety of topiramate for the prevention of pediatric migraine. The primary efficacy measure was the percentage reduction in the monthly migraine attack rate compared with baseline.…”