Fremanezumab helps prevent episodic migraine in youths

The use of fremanezumab is safe and effective for the prevention of episodic migraine (EM) in children and adolescents as young as 6 years old, according to a study presented at AAN 2025.

“Fremanezumab is a calcitonin gene-related peptide (CGRP) pathway monoclonal antibody approved for preventive migraine treatment in adults,” said lead author Dr Andrew D Hershey, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, US.

Hershey and his team conducted this multicentre, double-blind, parallel-group, phase III trial in participants aged 6–17 years, with a migraine diagnosis for at least 6 months and a history of ≤14 headache days/month. They randomized 237 participants 1:1 to receive monthly fremanezumab (<45 kg, 120 mg; ≥45kg, 225 mg) or placebo for 12 weeks.

The primary endpoint was the least-squares (LS) mean change from baseline in average monthly migraine days (MMD) during the double-blind period. The secondary endpoints were LS mean change from baseline in month headache days of at least moderate severity (MHD) and the proportion of participants achieving ≥50-percent decrease in MMD.

In addition, Hershey and colleagues carried out subgroup analyses based on age (6–11 and 12–17 years) and sex.

Of the participants, 234 were included in the efficacy analysis (6–11 years: n=63; 12–17 years; n=171; 129 females; 105 males). A total of 123 participants were in the fremanezumab arm and 111 in the placebo arm.

Compared with placebo, fremanezumab significantly reduced MMD over 3 months (–2.5 vs –1.4; p=0.0210). In subgroup analyses, LS mean changes from baseline in MMD also favoured fremanezumab over placebo when stratified by age (6–11 years: –3.4 vs –1.7; 12–17 years: –2.7 vs –1.8) and sex (male: –3.5 vs –2.2; female: –2.3 vs –1.5).

Likewise, the MHD reduction was significantly greater in the fremanezumab arm (–2.6 vs –1.5; p=0.01172), as well as the 50-percent response rate (47.2 percent vs 27.0 percent; p=0.0016).

Adverse events

In terms of safety, no significant difference was noted in the proportion of participants reporting one or more adverse events (AEs) between treatment groups (55 percent with fremanezumab vs 49 percent with placebo). Additionally, there were low proportions of participants with serious AEs (≤3 percent) and AEs leading to treatment discontinuation (<1 percent).

“These findings demonstrate the efficacy, safety, and tolerability of fremanezumab in children and adolescents with EM,” Hershey said.

“This is extremely significant," Dr Jessica Ailani, clinical professor of neurology at MedStar Georgetown University Hospital and director of the MedStar Georgetown Headache Center in Washington, DC, US, said in a separate opinion. [https://tinyurl.com/5cjem833]

“This is the first readout of study results for any of the anti-CGRP treatments for migraine prevention in the paediatric population, and as a field we've been holding our breath hoping for an effective treatment. This data is positive, and I'm extremely encouraged," she added.

Ailani was not part of the team that conducted this study.