Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
On December 5, 2024, we reported on findings from a phase 3 clinical trial evaluating the efficacy and safety of fremanezumab (Ajovy; Teva)for the prevention of episodic migraine in children and adolescent patients aged 6-17 years.
The study
The multicenter, randomized, double-blind, placebo-controlled, parallel-group SPACE trial included 237 patients aged 6 to 17 years who had been diagnosed with migraine for 6 months or more and had a history of less than 14 headache days a month. Investigators analyzed subgroups by age (6 -11 years and 12 -17 years) and by sex.
The findings
Over the study period of 3 months, treatment with fremanezumab resulted in significant reductions in monthly migraine days vs placebo (-2.5 vs -1.4; P = .021) and in monthly headache days (MHD) vs placebo (-2.6 vs -1.5; P = .017).
Results also showed a a significantly greater number of children (47.2%) reached a 50% response rate to fremanezumab vs to placebo (27.0%) over 12 weeks with a safety profile and efficacy consistent with results in pivotal phase 3 and real-world evidence studies in adults.
A similar proportion of children in the treatment and placebo groups reported 1 or more adverse events (55% and 49%, respectively). The proportion of participants with a serious AE and an AE that led to discontinuation of treatment was low in both groups (3% or less and 1% or less, respectively).
Authors' comments
"This is an important milestone for clinicians and young patients living with episodic migraine who currently have little treatment options available to them. This is the first Phase 3 trial of a CGRP-pathway treatment that has shown statistically superior efficacy with [favorable] safety and tolerability for the prevention of episodic migraine in children and adolescents."
