The Pharmacologic Prophylaxis of Pediatric Migraine: A Systematic Review, Survey and Design of a Randomized Controlled Trial

Abstract

Objectives: 1) To describe the state of the evidence for interventions in pediatric migraine, 2) to survey experts regarding non-inferiority margins in migraine research and 3) to design a clinical trial in this area of research.

Methods: A systematic review was carried out to identify randomized, placebo-controlled trials of pharmaceutical and nutraceutical interventions used to prevent migraine in children and adolescents, using Cochrane methods. Secondly, neurologists with expertise in Headache Medicine were invited to participate in a survey regarding their opinions on non-inferiority margins for outcomes used in clinical trials of migraine interventions. Thirdly, a protocol was written for a three-arm, parallel-group, randomized trial comparing the efficacy and safety of topiramate, levetiracetam and placebo for the prophylaxis of pediatric migraine.

Results: The systematic review identified 19 articles of 12 interventions for pediatric migraine. The quality of the evidence was poor and few conclusions could be made. Ninety-nine eligible respondents completed the survey and non-inferiority margins for six outcomes were determined. A randomized controlled trial protocol was developed to determine if topiramate and levetiracetam are superior to placebo, and if levetiracetam is non-inferior to topiramate for the prevention of migraines in children and adolescents.

Conclusions: It is hoped that the results of this thesis can be applied to further the evidence in this area of clinical research.