Prevention of Episodic Migraine in Children: Is Fremanezumab Safe and Effective?

Fremanezumab is effective and safe for the treatment of pediatric episodic migraine, according to study results presented at the 2025 American Academy of Neurology (AAN) annual meeting, held from April 5 to 9, 2025, in San Diego, California.

Fremanezumab is a monoclonal antibody targeting the calcitonin gene-related peptide pathway that is currently approved as a preventive migraine treatment for adult patients.

To assess the safety and efficacy of fremanezumab in the pediatric setting, researchers conducted the phase 3, randomized, double-blind, placebo-controlled trial SPACE (ClinicalTrials.gov Identifier: NCT04458857). Patients (N=234) aged 6 to 17 years diagnosed with migraine at least 6 months previously and who experienced 14 or fewer headache days per month were randomly assigned in a 1:1 ratio to receive fremanezumab (n=123) or placebo (n=111) for 12 weeks.

Fremanezumab was administered at a dose of 120 or 225 mg for patients weighing less than 45 kg or 45 kg or more, respectively.

The primary endpoint was the average change in monthly migraine days (MMD) from baseline.

The patients were aged 6 to 11 years (n=63) or 12 to 17 years (n=171) and 129 were girls.

During the 12-week treatment period, fremanezumab reduced MMD by a least-squares mean difference (LSMD) of 2.5 days compared with 1.4 days with placebo (P =.0210).

Stratified by age, fremanezumab was favored over placebo for reducing MMD among children aged 6 to 11 years (LSMD, -3.4 vs -1.7 days) and 12 to 17 years (LSMD, -2.7 vs -1.8 days), respectively.

Fremanezumab was also associated with a greater reduction in MMD relative to placebo among boys (LSMD, -3.5 vs -2.2 days) and girls (LSMD, -2.3 vs -1.5 days), respectively.

In the secondary analyses, fremanezumab associated with a significant reduction in the number of monthly headache days of at least moderate severity (LSMD, -2.6 vs -1.5 days; P =.0172) and a greater proportion of those who received fremanezumab achieved a 50% or greater reduction in MMD (47.2% vs 27.0%; P =.0016) compared with placebo, respectively.

More than half of those who received fremanezumab (55%) and nearly half of those who received placebo (49%) reported 1 or more adverse event. Serious adverse events occurred among 3% or less and adverse events leading to discontinuation among less than 1% in each group.

“These findings demonstrate the efficacy, safety, and tolerability of fremanezumab in children and adolescents with [episodic migraine],” the researchers concluded.

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