CGRP Antagonist Shows Promise in Preventing Episodic Migraine in Children and Adolescents
A recent phase 3 clinical trial has demonstrated that Ajovy (fremanezumab; Teva, Tel Aviv, Israel), a monoclonal antibody (mAb) calcitonin gene-related peptide (CGRP) antagonist, is effective and safe as a preventive treatment of episodic migraine (EM) in children and adolescents. Results of the SPACE study (NCT04458857) revealed that people who received Ajovy show significantly greater reductions in monthly migraine days compared with placebo, marking a potential advancement in pediatric migraine management, an area with limited preventive treatment options. The results were presented at the 2025 American Academy of Neurology Annual Meeting.
The multicenter, double-blind, parallel-group study included 234 participants aged 6 to 17 years who had been diagnosed with migraine for at least 6 months and experienced up to 14 headache days per month. Participants were randomized (1:1) to receive either monthly Ajovy (120 mg for those under 45 kg; 225 mg for those 45 kg or heavier) or placebo over a 12-week period. The primary end point measured the change in average monthly migraine days; secondary end points included a reduction in moderate-to-severe headache days and the proportion of participants achieving at least a 50% reduction in migraine frequency.
Results showed that Ajovy significantly outperformed placebo in reducing monthly migraine days (-2.5 vs. -1.4, P=.0210) during the treatment period, with efficacy demonstrated across all age- and sex-stratified subgroups. Notably, 47.2% of participants receiving Ajovy achieved at least a 50% reduction in monthly migraine days compared with only 27% in the placebo group (P=.0016). The safety profile was favorable, with similar adverse event rates between treatment (55%) and placebo (49%) groups, and low rates of serious adverse events (≤3%).
These findings represent an important development for pediatric neurology, as Ajovy could potentially address a significant unmet need in migraine prevention for younger patients. The SPACE trial provides compelling evidence that CGRP-targeted therapy, already established in adult migraine prevention, may also benefit children and adolescents suffering from EM with an acceptable safety and tolerability profile.
Source: Hershey AD, Szperka CL, Barbanti P, et al. Efficacy and safety of Ajovy for the preventive treatment of episodic migraine in children and adolescents: a phase 3, randomized, double-blind, placebo-controlled study. Presented at: American Academy of Neurology Annual Meeting; April 5–9, 2025; San Diego, CA.