OBJECTIVE: To describe baseline headache characteristics of children and 
adolescents participating in a multicenter, randomized, double-blinded, 
placebo-controlled, comparative effectiveness study of amitriptyline, 
topiramate, and placebo for the prevention of migraine (CHAMP Study).
METHODS: Children and adolescents (age 8-17 years old, inclusive) diagnosed with 
migraine with or without aura, having headaches at least four times per month 
were enrolled from 2012 through 2014. The trial involved a baseline period 
(minimum of 28 days) during which prospective diaries were completed and 
demographics and headache features obtained.
RESULTS: A total of 488 children and adolescents (mean age 14.0 ± 2.4 years) 
agreed to participate in the trial, with 361 randomized and 127 not randomized. 
Randomized subjects had a 5.5 ± 3.1 year history of headaches, with 15.1 ± 7.1 
headache days per month (based upon retrospective report at screening visit). 
Prospective diaries reported 11.5 ± 6.1 headache days per 28 day baseline. 
Across this 28 day period, reported headache days per week were stable (about 3 
headache days per week). Recording of individual headache features by diary 
(n = 4136 headache days) showed characteristics consistent with migraine (mean 
duration 10.5 ± 8.1 hours, mean severity 6.0 ± 2.1, 60% throbbing, 55% with 
activity worsening headaches, 55% with photophobia, and 47% with phonophobia).
CONCLUSIONS: Baseline data from the CHAMP Study suggested that the randomized 
sample was representative of the real world population of children and 
adolescents that present for treatment of migraine. Headaches in children and 
adolescents recorded during a 28 day prospective baseline period in this 
multi-site comparative effectiveness study did not change over the course of the 
baseline period, even though a clear diagnosis, recommendation for effective 
acute treatment, and standardized education about healthy habits occurred prior 
to the diary collection period.