Pediatric Migraine: The CHAMP Trial

Pediatric Migraine: The CHAMP Trial

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More than 6 million children and adolescents
in the United States have migraine headaches. Current clinical practice guidelines for pediatric
migraine are based on expert consensus, given the lack of evidence for specific therapy. The CHAMP trial aimed to assess the benefits
and harms of two of the most commonly used medications for the prevention of migraine
in pediatric patients. This phase 3, multicenter, double-blind, placebo-controlled
trial was conducted in the United States and enrolled children and adolescents 8 to 17
years old with a diagnosis of migraine causing at least mild disability and abaseline headache
frequency of at least 4 days per month. 361 patients were randomized in a 2:2:1 ratio
to oral amitriptyline, topiramate, or placebo for 24 weeks. The trial was stopped early for futility. For the 328 patients with data to analyze,
the primary outcome, a relative reduction of 50% or more in the number of headache days,
was no different in the three groups, orccurring in 52% of those in the amitriptyline group,
55% of those in the topiramate group, and 61% of those in the placebo group. There was also no difference in disability
scores. As compared with placebo, there was more fatigue
and dry mouth in the amitriptyline group and more paresthesias and weight loss in the topiramate
group. There were 12 serious adverse events reported
during treatment, including 3 patients with altered mood and 1 with syncope in the amitriptyline
group and 1 suicide attempt in the topiramate group. The authors conclude that in the 24 week CHAMP
trial, treatment with amitriptyline or topiramate as compared with placebo did not reduce the
frequency of headaches and was associated with more adverse events. Full trial results are available at NEJM.org.

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