Researchers observed no significant differences in headache frequency or headache-related disability in children or adolescents who received amitriptyline, topiramate, or placebo to treat migraines for a period of 24 weeks, according to data published in the New England Journal of Medicine.
Scott W. Powers, PhD, from the Department of Pediatrics at the University of Cincinnati College of Medicine, and colleagues conducted the Childhood and Adolescent Migraine Prevention (CHAMP) trial in children and adolescents between 8 and 17 years of age to determine which medication would prevent pediatric migraines.
The researchers randomly assigned 361 patients to receive amitriptyline, topiramate, or placebo. They included 328 participants in the primary efficacy analysis—132 received amitriptyline, 130 received topiramate, and 66 received placebo.
The primary outcome of the CHAMP trial was the relative reduction of 50% or more in the number of headache days from the 28-day baseline period to the last 28 days of the 24-week trial. The secondary outcomes were headache-related disability, headache days, number of participants who completed the trial, and serious adverse events that occurred during treatment. The investigators concluded the trial early owing to futility after a planned interim analysis.
The primary outcome occurred in 52% of patients who received amitriptyline, in 55% of patients who received topiramate, and in 61% of patients in the placebo group. The researchers observed no significant differences between the groups regarding headache-related disability, headache days, or the percentage of patients who completed the treatment.
Participants in the amitriptyline or topiramate groups had higher rates of adverse events compared with participants in the placebo group. Participants taking amitriptyline had higher rates of fatigue (30% vs 14%) and dry mouth (25% vs 12%) compared with the placebo group, and participants taking topiramate had higher rates of paresthesia (31% vs 8%) and weight loss (8% vs 0%) compared with the placebo group. The researchers also noted that 3 patients in the amitriptyline group experienced serious adverse events of altered mood and 1 patient had a suicide attempt.
“Given the null outcome in this trial and the adverse events and serious adverse events reported in the amitriptyline and topiramate groups, the data do not show a favorable risk-benefit profile for the use of these therapies in pediatric migraine prevention, at least over the 24-week duration of the trial,” the study authors wrote. “Our findings also suggest that the adult model of headache treatment, in which amitriptyline and topiramate have been effective, may not apply to pediatric patients.”
- Powers SW, Coffey CS, Chamberlin LA, et al. Trial of amitriptyline, topiramate, and placebo for pediatric migraine. N Engl J Med. 2016; doi:10.1056/NEJMoa1610384.