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A clinical trial can offer a child a chance for relief from painful headaches. An investigation examines whether the benefits of treatment in a migraine study were sustained, even after treatment ended.
Migraines can be debilitating and some children and adolescents may experience multiple migraine headache days every week. The Childhood and Adolescent Migraine Prevention (CHAMP) was used to study migraine treatment in children and a study in JAMA Pediatrics investigated whether the benefits the children found during the study were sustained afterwards.1
The CHAMP trial randomized children and adolescents into 3 groups: amitriptyline, topiramate, or placebo and ran for 24 weeks. When the trial ended, the drug or placebo was stopped and the participant was then given the clinical care of his or her choice going forward. The investigators sent out surveys at 3, 6, 12, 18, 24, and 36 months following the end of the trial. The surveys asked about headache days, disability, and ongoing use of prescription preventive medication.
The surveys sample included 205 participants who had an average history of migraine for 5.7 years. The sample retention over the course of the 36 month follow-up period was 189 participants (92%) at month 6, 182 participants (88%) at month 12, 163 participants (80%) at month 18, 165 participants (80%) at month 24, and 155 participants (76%) at month 36. During the follow-up period, the participants were found to maintain their meaningful reduction in headache days (mean [SD] headache days per 28 days: CHAMP baseline, 11.1 [6.0] days; CHAMP completion, 5.0 [5.7] days; 3-year follow-up, 6.1 [6.1] days) and disability (mean [SD] score: CHAMP baseline, 40.9 [26.4]; CHAMP completion, 17.9 [22.1]; 3-year follow-up, 12.3 [20.0]). At 3 years post-CHAMP study, the average number of headache days per week was 1.5, in comparison to 3 per week at baseline. Furthermore, the disability score had gone from moderate range to low-mild range. There were 153 participants who reported their prescription drug use at 3 years and only 1 participant stated that he or she used prevention medication for migraines. Furthermore, most of the participants did not report using medication at most of the studied timepoints.
The investigators concluded that the children with a long history of migraine in the CHAMP trial appear to maintain the positive outcomes seen in the trial, even when they are no longer receiving the preventive medication. However, further research is needed to understand the mechanisms of improving treatment as well as maintenance for prevention therapies.
1. Powers S, Coffey C, Chamberlin L, 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(7):e2114712. doi:10.1001/jamanetworkopen.2021.14712