BACKGROUND: Migraine is one of the most common health problems for children and 
adolescents. If not successfully treated, it can impact patients and families 
with significant disability due to loss of school, work, and social function. 
When headaches become frequent, it is essential to try to prevent the headaches. 
For children and adolescents, this is guided by extrapolation from adult 
studies, a limited number of small studies in children and adolescents and 
practitioner preference. The aim of the Childhood and Adolescent Migraine 
Prevention (CHAMP) study is to determine the most effective preventive agent to 
use in children and adolescents.
METHODS: CHAMP is a double-blinded, placebo-controlled, multicenter, comparative 
effectiveness study of amitriptyline and topiramate for the prevention of 
episodic and chronic migraine, designed to mirror real-world practice, sponsored 
by the US National Institute of Neurological Disorders and Stroke/National 
Institutes of Health (U01NS076788). The study will recruit 675 subjects between 
the ages of 8 and 17 years old, inclusive, who have migraine with or without 
aura or chronic migraine as defined by the International Classification of 
Headache Disorders, 2nd Edition, with at least 4 headaches in the 28 days prior 
to randomization. The subjects will be randomized in a 2:2:1 (amitriptyline: 
topiramate: placebo) ratio. Doses are weight based and will be slowly titrated 
over an 8-week period to a target dose of 1 mg/kg of amitriptyline and 2 mg/kg 
of topiramate. The primary outcome will be a 50% reduction in headache frequency 
between the 28-day baseline and the final 28 days of treatment (weeks 20-24).
CONCLUSIONS: The goal of the CHAMP study is to obtain level 1 evidence for the 
effectiveness of amitriptyline and topiramate in the prevention of migraine in 
children and adolescents. If this study proves to be positive, it will provide 
information to the practicing physician as how to best prevent migraine in 
children and adolescents and subsequently improve the disability and outcomes.