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First Pediatric RCT: Anti-CGRP Drug Fremanezumab Reduces Migraine Days in Children and Adolescents

RPEP-152892026Hershey, Andrew D; Szperka, Christina L; Barbanti, Piero; Pozo-Rosich, Patricia; Bittigau, Petra; Barash, Steve; Bryson, Juline; Kessler, Yoel; Carmeli Schwartz, Yael; Ramirez Campos, Verena; Ning, Xiaoping
evidence
The takeaway

Fremanezumab reduced migraine days by 1.1 more than placebo in 234 children/adolescents with episodic migraine, with 47.2% achieving ≥50% reduction vs 27.0% placebo (p=0.002).

47% cut migraines in half

Nearly half of children on fremanezumab had their migraine days reduced by at least 50% — the first anti-CGRP pediatric evidence

What the researchers found

Fremanezumab vs placebo: migraine days -2.5 vs -1.4 (difference 1.1, p=0.02); moderate-severe headache days -2.6 vs -1.5 (p=0.02); ≥50% responder: 47.2% vs 27.0% (p=0.002). Injection-site erythema: 9.8% vs 5.4%.

Why it matters

Migraine in children is undertreated because few drugs have pediatric evidence. This is the first anti-CGRP drug proven effective in children, potentially changing pediatric migraine management.

How the study worked

Randomized, double-blind, placebo-controlled trial (NCT04458857) in 237 participants aged 6-17 with episodic migraine, monthly SC fremanezumab (120 mg <45 kg, 225 mg ≥45 kg) vs placebo for 3 months.

What this study cannot tell us

3-month treatment only. Longer safety data needed in growing children. 237 participants is moderate. No head-to-head with other pediatric migraine drugs.

How to read the evidence

Randomized double-blind placebo-controlled trial in children — the gold standard. First of its kind for anti-CGRP drugs.

When this study was published

Published in 2025, NCT04458857.

The bigger picture

Anti-CGRP drugs have transformed adult migraine treatment. Proving efficacy in children opens this revolutionary therapy to the youngest migraine sufferers.

Questions still open

  • Is fremanezumab safe for long-term use in growing children?
  • Should it become first-line for pediatric migraine?
  • Do other anti-CGRP drugs show similar pediatric efficacy?

Common questions

Can children take anti-CGRP migraine drugs?
This first pediatric trial showed fremanezumab safely reduced migraine days in children as young as 6. Nearly half had their migraines cut in half. Injection-site redness was the main side effect.
Is this approved for children?
Not yet approved for pediatric use, but this trial provides the evidence needed for potential approval. It is the first randomized controlled trial of any anti-CGRP drug in children.

Read the original research

Fremanezumab in Children and Adolescents with Episodic Migraine.

The New England journal of medicine, 394(3), 243-252

View on PubMed ↗Publisher’s paper ↗

Citation

Hershey, Andrew D; Szperka, Christina L; Barbanti, Piero; Pozo-Rosich, Patricia; Bittigau, Petra; Barash, Steve; Bryson, Juline; Kessler, Yoel; Carmeli Schwartz, Yael; Ramirez Campos, Verena; Ning, Xiaoping. (2026). Fremanezumab in Children and Adolescents with Episodic Migraine.. The New England journal of medicine, 394(3), 243-252. https://doi.org/10.1056/NEJMoa2504546