Phase 3 data presented at AAN 2026 show fremanezumab significantly reduces monthly migraine days in pediatric episodic migraine but not chronic migraine.
Results from two randomized, placebo-controlled phase 3 studies presented at the 2026
The findings, presented by Andrew Hershey, MD, PhD, director of the Headache Center at Cincinnati Children’s Hospital Medical Center, come from 2 multicenter trials evaluating fremanezumab in children and adolescents aged 6 to 17 years with episodic (EM) and chronic migraine (CM). Participants were randomized 1:1 to monthly fremanezumab (<45 kg, 120 mg; ≥45 kg, 225 mg) or placebo over a 3-month double-blind period, with change in monthly migraine days (MMD) as the primary end point.¹
In the episodic migraine cohort (n = 234), fremanezumab demonstrated a significantly greater reduction in MMD compared with placebo (–2.5 vs –1.4; P = .0210).¹ Secondary outcomes were also met, including reductions in monthly headache days of at least moderate severity (–2.6 vs –1.5; P = .0172) and a higher ≥50% response rate (47.2% vs 27.0%; P = .0016).¹ These findings indicate a clinically meaningful reduction in migraine burden over the 12-week treatment period.
By contrast, the chronic migraine cohort (n = 289) did not show a significant difference between fremanezumab and placebo for the primary end point (–3.8 vs –3.7; P = .8484).¹ The lack of separation highlights ongoing challenges in treating pediatric chronic migraine, where placebo responses and disease heterogeneity may influence trial outcomes.
Abbreviations: MMD, monthly migraine days.
Fremanezumab, a monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) pathway, works by inhibiting CGRP-mediated signaling involved in migraine pathophysiology. The agent was initially approved in 2018 for adult migraine prevention and later received FDA approval in 2025 for pediatric episodic migraine in patients aged 6 to 17 years, marking the first anti-CGRP therapy indicated for this population.2
The results presented at AAN 2026 are consistent with prior findings from the phase 3 SPACE study, which supported the pediatric indication and demonstrated similar reductions in MMD (–2.5 vs –1.4; P = .0210) and MHD (–2.6 vs –1.5; P = .0172), along with a 47.2% ≥50% response rate among treated patients.² The reproducibility of these findings across studies strengthens the evidence base supporting fremanezumab in pediatric episodic migraine.
Safety outcomes in the current analysis were comparable between treatment and placebo groups, with similar rates of adverse events and infrequent serious adverse events or discontinuations.¹ These findings align with the established safety profile observed in both adult and pediatric trials of fremanezumab.
Overall, the data from SPACE further supported fremanezumab as an effective preventive option for pediatric episodic migraine, while underscoring the need for additional research to address unmet treatment needs in chronic migraine populations.
