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Fremanezumab reduces migraine frequency in children and adolescents with episodic migraine
1. In this randomized controlled trial involving pediatric patients, fremanezumab led to greater reductions in the number of migraine days per month versus placebo, consistent with previous trials in adults.
2. Fremanezumab had a favorable safety profile, with the most common adverse event being injection site reactions.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Fremanezumab (Ajovy) is a humanized monoclonal antibody that targets calcitonin gene-related peptide (CGRP). It has been shown to significantly reduce headache frequency and need for acute medications and is currently approved for episodic and chronic migraine prevention in adults. However, there is limited evidence of the drug’s effectiveness among the pediatric population, with results largely being observed in retrospective cohort studies. This randomized controlled trial was conducted to determine fremanezumab’s efficacy and safety in children and adolescents with episodic migraine. It was found that, compared to placebo, fremanezumab led to a greater reduction in the number of headache days per month and in the use of acute headache medication. Nearly fifty percent of those using fremanezumab experienced more than a halving of the number of migraine days per month, compared to approximately one-quarter of those in the placebo group. While the fremanezumab group had a slightly higher incidence of adverse events, nearly all events were mild to moderate in severity; severity did not vary significantly between trial groups. Further, there was no detectable difference in adverse events between children and adolescents. Strengths of this study included broad inclusion criteria and implementation of measures to reduce placebo response. Limitations were a small sample size and relatively short follow up. Overall, these results showed that fremanezumab was efficacious and tolerable for the prevention of episodic migraine in children and adolescents. Based on this study’s findings, the Food and Drug Administration has since expanded approval to include pediatric populations.
Click to read the study in NEJM
In-Depth [randomized controlled trial]: This phase 3, multicenter, double-blind randomized controlled trial was conducted to determine the safety and efficacy of fremanezumab for migraine prevention in children and adolescents. To be eligible for inclusion, participants must have been diagnosed with episodic migraine, defined as migraine for ≥6 months and a history of ≤14 headache days per month. Up to 30% of participants could be taking up to two concomitant migraine-preventives. Exclusion criteria included clinically significant comorbidity, use of opioids or barbiturates, or history of hemiplegic migraine. A total of 237 individuals aged 6 to 17 meeting these criteria were stratified and randomly assigned in a 1:1 ratio to receive either monthly subcutaneous injections of fremanezumab or placebo. The primary endpoint was the least-squares mean change from baseline in mean number of migraine days per month. The fremanezumab group had a significantly higher decrease (-2.5 days; 95% confidence interval [CI], -3.2 to -1.7) in migraine days than the placebo group (-1.4 days; 95% CI, -2.2 to -0.7). In total, 47.2% of children on fremanezumab experienced a 50% or greater reduction in migraine days, compared to 27% of those receiving placebo (odds ratio [OR], 2.5; 95% CI, 1.4 to 4.4; p=0.002). Other secondary endpoints included change from baseline in the number of headaches of at least moderate severity and in the number of days acute headache medication was used. Both secondary endpoints met the threshold for statistical significance, with fremanezumab leading to greater reductions in both metrics. Improvements in questionnaire data measuring migraine disability and patient impression of improvement were similar between groups. While a higher proportion of those on fremanezumab (55.3%) experienced adverse events than placebo (49.1%), the majority were nonserious injection site reactions. In summary, this randomized-controlled trial demonstrated fremanezumab’s efficacy and safety as prophylaxis for episodic migraine in children and adolescents.
Image: PD
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