Children and adolescents with longstanding migraine experience meaningful improvements in headache status for up to three years after treatment in the Childhood and Adolescent Migraine Prevention (CHAMP) trial.
The CHAMP trial which compared amitriptyline, topiramate and placebo in 8-17 year olds with migraine was stopped early due to futility. It found neither of the two preventive medications was more effective than placebo in reducing the number of headache days over 24 weeks.
However the follow-up study, published in JAMA Network Open and comprising online surveys in 205 original participants, found evidence of an enduring treatment effect.
At the end of the 3-year follow-up, participants experienced a mean of 6.1 headache days per month, compared with 11.1 at baseline and 5.0 at the end of the CHAMP trial.
The mean overall Paediatric Migraine Disability Assessment Scale (PedMIDAS) score was 12.3, compared with 40.9 at baseline and 17.9 at the end of the original trial.
Use of prescription preventive medication during the follow-up period was reported by less than 10% of participants.
Again, there was no significant difference between the original treatment groups.
The investigators said the meaningful clinical improvement did not appear to be associated with the pharmacological action of preventive medications.
Instead, they suggested the expectation of response or fluctuations of disease severity may explain their findings.
“It remains unclear how and why youth with migraine improve and maintain these improvements over time with pharmacotherapy interventions, with the placebo effect, and with nonpharmacological interventions, such as cognitive behavioural therapy.”
“Clinicians should leverage potential expectation effects and use a multidisciplinary model that incorporates this expectation with acute treatment, healthy lifestyle practices, and headache education to help improve the lives of children and adolescents with migraine and their families.”
An Invited Commentary in the journal said the study reinforced the fact that “treating paediatric migraine is not simply the same as treating adult migraine with lower doses”.
“Although we suspect there is indeed a subset of paediatric patients who will require long-term preventive migraine treatment, the CHAMP 3-year follow-up study serves as a welcome reminder that we should continually look to discontinue medication when it is no longer needed, and that when this is accomplished, there is the potential for sustained relief.”
“It also prompts the question of whether there is a biological explanation of why some patients exhibit sustained benefits from medical interventions. Uncovering which factors—biological and nonbiological—are associated with sustained benefit will further advance our management of paediatric migraine.”