Describe a prospective multi-site, pediatric migraine registry collecting real world data to support regulatory submissions and facilitate conduct of future clinical trials in children and adolescents with migraine. 

Migraine is common in children and adolescents, and can cause substantial pain and disability. Recent treatment guidelines from the Â鶹´«Ã½Ó³»­/American Headache Society highlight the relative paucity of safe and effective treatments for migraine in these age groups, particularly for prevention.  

Those aged 4-17 years who met International Classification of Headache Disorders, 3^rdedition for migraine were eligible. There were no restrictions with regards to frequency, severity, or aura status. The enrollment period described covers 12/2018 to 08/2019, with each participant providing headache and clinical data for the initial visit and 4 additional follow-up visits in person and via a mobile device based migraine diary.

18 of 20 sites have activated and started enrollment, for a total of 102 participants enrolled to date, with the anticipated completion of enrollment (200 participants) in 12/19.  Median age of participants is 14 years (IQR 11-16), and two-thirds are female (69/104, 66.3%).  Median headache frequency/month is 13 (IQR 8-25). In this real-world registry, classes of acute and preventive medications expanded beyond the categories of medications recommended in the migraine guidelines: most commonly used were NSAIDs, triptans, tricyclic antidepressants, and topiramate.  

A pediatric migraine registry that collects real-world data is feasible to create and maintain.  In addition to collecting data in a regulatory compliant manner, the registry creates a ready for use infrastructure for the conduct of future clinical trials in children and adolescents with migraine.