The use of fremanezumab in children and adolescents with episodic migraine (EM) results in significant reductions in monthly migraine days (MMD) and monthly headache days (MHD), but it appears to be no better than placebo among those with chronic migraine (CM), as shown by outcomes from two randomized, phase III trials presented at AAN 2026.
Furthermore, fremanezumab has shown acceptable safety and tolerability profiles that are consistent with those observed in previous trials involving adult participants. [JAMA 2018;319:1999-2008; N Engl J Med 2017;377:2115-2122]
“Treatment with fremanezumab led to significant reductions in MMD, MHD of at least moderate severity, and days with acute headache medication use in children and adolescents with EM,” says study co-author and presenter Dr Juline Bryson, Teva Branded Pharmaceuticals Products, R&D, LLC, West Chester, Pennsylvania, US.
The two multicentre, phase III studies involved participants aged 6‒17 years with a migraine diagnosis for at least 6 months and a history of ≤14 (EM) or ≥15 headache days/month (CM). They were randomly allocated 1:1 to monthly fremanezumab (<45 kg, 120 mg; ≥45 kg, 225 mg) or placebo for 3 months.
The primary endpoint was least squares mean change from baseline in average MMD during the 3-month double-blind period, while secondary endpoints included the mean change from baseline in MHD, ≥50-percent MMD response rates, and safety.
The efficacy analyses included 234 and 289 participants from the EM and CM studies. Compared with placebo, treatment fremanezumab led to a significant decrease in MMD (‒2.5 vs ‒1.4; p=0.0210) in the EM study. However, in the CM study, the difference did not reach statistically significance (‒3.8 vs ‒3.7; p=0.8484). [Hershey AD, et al, AAN 2026]
Not superior
Among participants with CM, “reductions in MMD were observed in both treatment groups, [but] fremanezumab was not superior to placebo, and the primary endpoint was not met,” Bryson said.
On the other hand, fremanezumab use achieved significantly greater reduction in MHD compared with placebo (‒2.6 vs ‒1.5; p=0.0172) among children and adolescents with EM. Moreover, the ≥50-percent MMD response rate was substantially higher in the fremanezumab group than the placebo group (47.2 percent vs 27.0 percent; p=0.0016).
With regard to safety, no significant between-group difference was seen in the frequency of adverse events (AEs), while serious AEs and those that led to treatment discontinuation rarely occurred.
“Preliminary results from the 9-month open-label extension support the long-term safety and tolerability of fremanezumab in this population, with no new safety signals reported,” Bryson said.
Monoclonal antibody
Fremanezumab is a calcitonin gene-related peptide pathway monoclonal antibody that has been shown to be safe and efficacious in several randomized controlled trials in adults with EM and CM, but data related to its use in paediatric patients remain scarce. [JAMA 2018;319:1999-2008; N Engl J Med 2017;377:2115-2122; Lancet 2019;394:1030-1040]
Migraine is relatively common among children and adolescents, with an estimated prevalence of 11 percent. [J Headache Pain 2023;24:8]
“Children and adolescents with migraine experience significant burden, resulting in school absence, impaired educational performance, and missed social activities,” Bryson said. [Curr Pain Headache Rep 2017;21:45]