Pediatric migraine drug effectiveness trial falls short
medwireNews: Current medications prescribed for the treatment of migraine in children and adolescents appear to be no more effective than placebo, findings from the CHAMP study indicate.
The Childhood and Adolescent Migraine Prevention (CHAMP) trial, which was stopped early due to ineffectiveness, compared amitriptyline, topiramate, and placebo in 328 children and adolescents aged 8 to 17 years with a migraine frequency of at least 4 days in the preceding month.
The study was intended to provide guidance on the most effective first-line treatment, but the results showed that over a 24-week period, the 132 patients taking amitriptyline (target dose of 1 mg/kg per day) and the 130 taking topiramate (2 mg/kg per day) were no more likely than the 66 taking placebo to experience at least a 50% reduction in headache days.
From the 28 days prior to treatment to the final 4 weeks of the study, this endpoint was achieved by 52% of those taking amitriptyline, 55% of those taking topiramate, and 61% of placebo-treated patients. There was no significant difference between the two active treatments or between either of the treatments and placebo.
The three groups were also comparable in terms of reduced headache-related disability on the Pediatric Migraine Disability Assessment Scale, number of headache days, and response rates.
The only difference was the higher rate of side effects with the two active drugs, compared with placebo; the most common were fatigue (30 vs 14%) and dry mouth (25 vs 12%) in patients taking amitriptyline, and paresthesia (31 vs 8%) and decreased weight (8 vs 0%) in those taking topiramate.
There were five serious adverse events deemed treatment-related: three instances of altered mood and one case of syncope in the amitriptyline group and one case of suicide attempt in the topiramate group.
The researchers, led by Scott Powers (University of Cincinnati College of Medicine, Ohio, USA), say in The New England Journal of Medicine that “the trial results suggest that prevention medication for pediatric migraine might be reexamined.”
Powers also pointed out in a press statement that the pediatric headache centers from which the children were enrolled all followed a multidisciplinary approach that included acute therapy, preventive therapy, and behavioral treatment.
He suggested that that first-line prevention treatment for children and adolescents should involve this approach and a “focus on non-pharmacological aspects of care.”
By Lucy Piper
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