Levetiracetam for Prophylactic Treatment of Pediatric Migraine: A Randomized Double-Blind Placebo-Controlled Trial Publisher Pubmed



Montazerlotfelahi H¹ ; Amanat M² ; Tavasoli AR³ ; Agah E^{2, 4} ; Zamani GR³ ; Sander JW^{5, 6, 7} ; Badv RS³ ; Mohammadi M³ ; Dehghani M⁸ ; Heidari M³ ; Hosseini SA⁹ ; Salehi M² ; Ashrafi MR³ Show Affiliations
Source: Cephalalgia Published:2019

Abstract

Introduction: Few drugs are available for migraine prophylaxis in children. Levetiracetam is a broad-spectrum anti-seizure drug that has been suggested to be effective in reducing adult migraine episodes. We assessed the safety and efficacy of levetiracetam in the prevention of pediatric migraine. Methods: A randomized double-blind placebo-controlled trial was performed. Eligible participants were aged 4–17 years old with at least four migrainous episodes monthly or had severe disabling or intolerable episodes. Primary endpoints were the mean changes in monthly frequency and intensity of headaches from the baseline phase to the last month of the double-blind phase. Safety endpoint was the adverse effects reported. Results: Sixty-one participants (31 taking levetiracetam and 30 taking placebo) completed the study. All had a significant reduction in frequency and intensity of episodes that was significantly greater in the levetiracetam arm. Sixty eight percent of individuals in the treatment group reported more than 50% reduction of episodes at the end of the trial compared with 30% in the placebo group (p-value: 0.007). Irritability, day-time sedation, and mild tic were reported. Conclusion: Levetiracetam may be useful in migraine prevention and may decrease migraine episodes and severity. Trial Registration: The study is prospectively registered with Iranian Registry of Clinical Trials; IRCT.ir, number IRCT2017021632603N1. © International Headache Society 2019.