Kids with Migraine Respond Differently to Preventive Treatment
Few drug trials are ever conducted on children owing to ethical concerns about exposing children to potential adverse events. Pediatricians and specialists who treat children and adolescents have very little clinical evidence to guide their treatment decisions. Most rely on the combined opinion of experts in their respective fields and prescribe off-label treatments in the hope that something will work.
The NIH finally comes through
In a rare move by the NIH, the Cincinnati Children’s Hospital Medical Center was awarded a grant for The Childhood and Adolescent Migraine Prevention Study (CHAMP). This week the first results from that study were published in the New England Journal of Medicine.
The goal of this 5-year study was to determine the effectiveness of both amitriptyline and topiramate compared to placebo for the prevention of pediatric migraine. 361 children, ages 8 to 17 were enrolled in this study. 132 received amitriptyline, 130 received topiramate, and 66 received a placebo treatment.
Each treatment was deemed successful if it reduced the frequency and/or severity of migraine by 50%. 52% of kids receiving amitritptyline saw sufficient relief. 55% of those receiving topiramate also got relief. What you may find surprising is that 61% of the children in the placebo group also saw a reduction in migraine attacks.
852 adverse events were reported by all participants. 301 adverse events occurred in those taking amitriptyline, including 3 instances of altered mood. 419 adverse events occurred with topiramate, including 1 suicide attempt. There were no deaths. The most common side effects were fatigue and dry mouth (amitriptyline), paresthesia, decreased weight, fatigue, dry mouth, memory impairment, aphasia, cognitive disorder, and upper respiratory tract infection (topiramate).
Given the high rate of adverse events combined with the high placebo rate, the study was terminated early. The risks of adverse events simply outweighed the demonstrated benefit of either drug. Researchers concluded that both amitriptyline and topiramate were no more effective than placebo at preventing migraine attacks. This finding is significantly different than results of studies on the use of either drug for adults.
Apparently, pediatric migraine requires a very different approach. Kid are not just miniature adults. We need to develop treatment strategies specific to children rather than relying on lower doses of adult preventives.
Why this matters
Most kids who develop migraine will continue to experience migraine as adults. Given the $36 billion drain on our economy due to migraine, it is essential that we find effective treatments for pediatric migraine. Successful early intervention can prevent a lifetime of suffering and poverty. As a society, we need to address this, both for humanitarian and economic reasons. The wasted talent due to decades of disability is a tragedy. We must find a way to stop migraine early in life so kids can live up to their potential.
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