Fremanezumab prevents pediatric episodic migraine better
Monthly fremanezumab reduced migraine and headache days in children and adolescents compared with placebo.
*Randomized placebo-controlled trial; Level 1b (OCEBM).

Citation

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:10.1056/NEJMoa2504546.

Background

Preventive options for pediatric migraine are limited, and evidence for newer targeted medicines in children has been scarce. This trial tested whether fremanezumab can prevent episodic migraine in ages 6 to 17 years.

Patients

Children and adolescents (6–17 years) with episodic migraine (4 to 14 headache days per month).

Intervention

Monthly under-the-skin fremanezumab for 3 months (120 mg if <45 kg; 225 mg if ≥45 kg).

Control

Matched placebo injections monthly for 3 months.

Outcome

Change in migraine days per month; key secondary outcomes included moderate-or-worse headache days, 50% response, and acute medicine-use days.

Follow-up Period

3 months (double-blind treatment period).

Results

Outcome (over 3 months) Fremanezumab Placebo Effect
Migraine days per month (primary) −2.5 days −1.4 days Difference −1.1 days (95% CI, −1.9 to −0.2)
Moderate-or-worse headache days per month −2.6 days −1.5 days Difference −1.1 days (95% CI, −2.1 to −0.2)
Acute headache medicine-use days per month −2.1 days −1.0 days Difference −1.1 days (95% CI, −1.8 to −0.4)
≥50% reduction in migraine days 47.2% 27.0% Odds ratio 2.5 (95% CI, 1.4 to 4.4); NNT=5
Injection-site redness was the most common side effect (9.8% vs 5.4%).

Limitations

Only 3 months of blinded follow-up; longer-term safety unknown. Sponsor funded and performed statistical analyses. Some patient-centered scores did not improve versus placebo.

Funding

Teva Pharmaceuticals; sponsor provided drug and conducted statistical analyses.

Clinical Application

For pediatric episodic migraine needing prevention, consider monthly fremanezumab; benefits are modest but clinically meaningful, with mainly injection-site reactions and limited short-term safety data.