Fremanezumab Trial Shows Benefit in Pediatric Episodic Migraine

Key Takeaways

• Fremanezumab was associated with a larger reduction in monthly migraine days than placebo during the randomized 3-month comparison.
• Days with at least moderate headache severity also declined more, and 47.2% of fremanezumab-treated participants reached a 50% migraine-day reduction versus 27.0% with placebo.
• Injection-site erythema was the most common adverse event, and the investigators noted that longer follow-up is needed to clarify efficacy and safety.

Over 3 months, monthly migraine days fell more with fremanezumab than with placebo in a randomized phase III trial in children and adolescents with episodic migraine. Among participants aged 6 to 17 years, average migraine days per month declined by 2.5 with fremanezumab and 1.4 with placebo, a 1.1-day difference; P = 0.02. Participants received monthly subcutaneous fremanezumab or matched placebo during the 3-month treatment period.

The multicenter phase III study enrolled participants aged 6 to 17 years with episodic migraine and was described in a PubMed-indexed trial abstract. Eligibility required migraine for at least 6 months and a history of 14 or fewer headache days per month. Participants were randomly assigned to monthly subcutaneous fremanezumab or matched placebo for 3 months, using 120 mg below 45 kg and 225 mg at 45 kg or higher. The primary endpoint was change from baseline in average migraine days per month, and participants could use migraine-specific medications for acute headaches. Of 237 randomized participants, 234 formed the full analysis population, including 123 assigned to fremanezumab, with 36 receiving 120 mg and 87 receiving 225 mg, and 111 assigned to placebo.

Beyond the primary endpoint, days per month with headache of at least moderate severity decreased by 2.6 with fremanezumab and 1.5 with placebo. The between-group difference was 1.1 days, with P = 0.02. A reduction of at least 50% in migraine days per month occurred in 47.2% of the fremanezumab group and 27.0% of the placebo group, with P = 0.002. These secondary efficacy measures aligned with the primary outcome.

For safety, injection-site erythema was the most common adverse event, reported in 9.8% of the fremanezumab group and 5.4% of the placebo group. The investigators said longer follow-up is required to better understand efficacy and safety in this pediatric population.