Study Shows Sustained Improvement in Headaches and Disability in Children and Adolescents with Migraines After a Prevention Trial

March 2022

Migraines may begin in childhood, but there is little evidence for effective pharmacologic therapies in children and adolescents. Instead, these patients often receive therapies that were only tested in clinical trials for adults.

The Childhood and Adolescent Migraine Prevention (CHAMP) study was a randomized placebo-controlled trial of children and adolescents with migraines treated with amitriptyline or topiramate, which are commonly prescribed therapies. The CHAMP intervention trial was stopped for futility after an interim analysis showed no differences in several outcomes between the placebo group and the treatment groups, although both groups experienced reductions in headache days and disability.

In this longitudinal follow-up study, the investigators examined whether these improvements were sustained.

Participants in the original CHAMP trial who agreed to be in the follow-up study received online surveys for 36 months after the end of the trial. The survey asked participants how many headaches they had in the past 28 days and what prescription medications they were taking for headaches over the previous 3 months. They also completed the Pediatric Migraine Disability Assessment Scale.

The primary outcomes were self-reported days with a headache per month, disability, and the percentage of participants who used prescription medication for migraine prevention.

From the 361 participants in the original CHAMP trial, a total of 205 completed the 3-month survey, and 155 completed a 3-year survey. The mean age of survey participants was 14.2 years, and the mean history of migraines was 5.7 years.

The mean number of headache days per month declined from 11.1 at baseline to 5.0 at the end of the 24-week intervention during the original CHAMP trial for the subgroup of participants who were in the follow-up trial. This improvement was maintained during the 3-year follow-up, with a mean number of headache days per month of 6.1 with no differences among the original placebo, amitriptyline, and topiramate treatment groups.

There were also no significant differences between groups for headache disability scores, which declined to the low mild range at 36 months of follow-up. Fewer than 8% of participants used prescription medications for headaches during the follow-up period in any of the groups.

The investigators do not know why there were strong improvements in the placebo and the treatment groups in the CHAMP trial and why these improvements were sustained for an additional 3 years. “To address these questions, future research should investigate whether neurobiological or pain processing changes, functional changes in brain activity, psychological factors, or treatment expectation changes that can result from an intervention are unique to a particular treatment,” they advised.

Regardless of the mechanism for the improvement of migraine burden during the CHAMP trial and follow-up, the investigators suggested that the results provide clinicians with some potentially valuable information. “For clinicians, the implication of this unique trial follow-up survey study is that once an individual’s headache frequency and disability has improved, this change may be continued and sustained without future pharmacological treatment or health care utilization,” they concluded.


Powers SW, Coffey CS, Chamberlin LA, et al. Prevalence of headache days and disability 3 years after participation in the Childhood and Adolescent Migraine Prevention Medication Trial. JAMA Netw Open. 2021;4:e2114712.

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