Fremanezumab Shows Significant Efficacy for Pediatric Episodic Migraine in Phase 3 Trial

Monthly treatment with fremanezumab was associated with statistically significant reductions in migraine frequency and headache burden compared with placebo in children and adolescents with episodic migraine, according to results from a randomized, placebo-controlled trial.¹

The findings address a key evidence gap in pediatric migraine prevention, an area where treatment options remain limited despite the high prevalence and functional impact of migraine in younger populations.¹

"Helping to prevent migraine attacks in children and adolescents is critical to supporting their healthy development and education, including missed school days, disability and overall social well-being," lead author Andrew D. Hershey, M.D., Ph.D., and Endowed Chair and Director of Neurology at Cincinnati Children’s Hospital Medical Center, said in a press release. "The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (AJOVY) can significantly reduce the frequency of attacks of migraine in youth, giving physicians critical evidence to guide care for this underserved population."²

The study enrolled children and adolescents aged 6 to 17 years with a diagnosis of episodic migraine, defined as migraine for at least 6 months and a history of no more than 14 headache days per month. Participants were randomly assigned to receive monthly subcutaneous injections of fremanezumab or matched placebo for 3 months. Fremanezumab dosing was weight based: 120 mg for participants weighing less than 45 kg and 225 mg for those weighing 45 kg or more.¹

Participants were permitted to continue using migraine-specific medications for acute headache treatment during the trial.¹

The primary end point was the change from baseline in the average number of migraine days per month. Key secondary end points included changes in the number of days per month with headache of at least moderate severity and the proportion of participants achieving a reduction of 50% or more in monthly migraine days.¹

Of the 237 participants who underwent randomization, 234 were included in the full analysis population, with 123 assigned to fremanezumab and 111 to placebo. Among those receiving fremanezumab, 36 participants received the 120-mg dose and 87 received the 225-mg dose.¹

Over the 3-month treatment period, participants receiving fremanezumab experienced a mean reduction of 2.5 migraine days per month, compared with a reduction of 1.4 days in the placebo group (difference, 1.1 days; P = .02).¹

Fremanezumab was also associated with greater reductions in headache days of at least moderate severity. Participants in the active treatment group reported a decrease of 2.6 days per month, compared with a 1.5-day reduction in the placebo group (difference, 1.1 days; P = .02).¹

Nearly half of participants treated with fremanezumab achieved a reduction of 50% or more in monthly migraine days (47.2%), compared with 27.0% of participants receiving placebo (P = .002).¹

Injection-site erythema was the most commonly reported adverse event and occurred in 9.8% of participants in the fremanezumab group, compared with 5.4% in the placebo group.¹

The investigators concluded that fremanezumab resulted in greater reductions in both migraine days and headache days than placebo in children and adolescents with episodic migraine. They emphasized that longer-term follow-up is needed to further characterize the efficacy and safety of the therapy in pediatric populations.¹

References:

1. Hershey AD, Szperka CL, Barbanti P, et al. Fremanezumab in Children and Adolescents with Episodic Migraine. N Engl J Med. 2026;394:243-252. doi:https://doi.org/10.1056/nejmoa2504546
2. Teva. AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine. Teva. January 14, 2026. Accessed January 15, 2026. https://www.tevapharm.com/news-and-media/latest-news/ajovy-fremanezumab-vfrm-significantly-reduced-monthly-migraine-and-headache-days-in-children-and-adole/