Fremanezumab Reduces Monthly Migraine Days in Children and Adolescents

Fremanezumab is associated with a significant reduction in monthly migraine days among children and adolescents with episodic migraine, according to study results presented at the 2025 American Headache Society (AHS) Annual Scientific Meeting, held from June 19-22, in Minneapolis, Minnesota, and virtually.

Fremanezumab is a humanized monoclonal antibody that is approved by the United States (US) Food and Drug Administration (FDA) for the treatment of migraine among adults.

To assess the safety and efficacy of fremanezumab in the pediatric setting, researchers from the SPACE (ClinicalTrials.gov Identifier: NCT04458857) trial recruited children aged 6 to 11 years (n=64) and adolescents aged 12 to 17 years (n=171) with episodic migraine. The patients were randomly assigned to receive 120 or 225 mg subcutaneous fremanezumab, depending on weight (n=123) or placebo (n=112) once a month for 4 months. The primary outcome was the average change in monthly migraine days from baseline. Episodic migraine was defined as experiencing fewer than 15 headache days per month.

The children and adolescents were mean age 13.3 to 13.4 years, 55% were girls, and 77% were White.

Fremanezumab was associated with an average decrease in monthly migraine days of -2.5 days compared with -1.4 days with placebo (P =.0210).

These trends were similar in the subgroup analyses. Fremanezumab was associated with a greater decrease in monthly migraine days compared with placebo in children (mean reduction, -3.4 vs -1.7 days), adolescents (-2.7 vs -1.8 days), boys (-3.5 vs -2.2 days), and girls (-2.3 vs -1.5 days), respectively.

Fremanezumab also elicited a greater decrease in monthly headache days (mean, -2.6 days) than placebo (mean, -1.5 days; P =.0172). More fremanezumab recipients reported a 50% reduction in headache days from baseline (47.2%) than placebo recipients (27.0%; P =.0016).

Fremanezumab had a similar safety profile as placebo, with 55% and 49% reporting adverse events and 2% and 3% reporting serious events, respectively.

The most common safety signals with fremanezumab were infections and infestations (27%) and general disorders and administration site conditions (21%). Stratified by dose, more high-dose recipients reported general disorders and administration site conditions (24% vs 14%) and skin and subcutaneous tissue disorders (10% vs 3%) and fewer reported respiratory, thoracic, and mediastinal disorders (3% vs 11%) than low-dose recipients, respectively.

“In the randomized, placebo controlled, double-blind study of fremanezumab for children and adolescents with <15 headache days per month, there was a significant improvement for fremanezumab compared with placebo (primary endpoint). Adverse events were comparable with fremanezumab versus placebo and overall was well-tolerated,” the researchers concluded.

Disclosure: This research was supported by Teva Pharmaceuticals. Please see the original reference for a full list of disclosures