Document resource
Introduction Fremanezumab, a calcitonin gene-related peptide monoclonal antibody, is approved for preventive migraine treatment in adults. The multicentre, parallel-group, Phase 3 SPACE study ( NCT04458857) evaluated the efficacy and safety of fremanezumab in children and adolescents with episodic migraine (EM).Methods Eligible participants (aged 6–17 years, migraine diagnosis for ≥6 months and history of ≤14 headache days/month) were randomised 1:1 to monthly fremanezumab (120 mg for <45kg, 225 mg for ≥45kg) or placebo. Primary endpoint: least-squares mean change from baseline in monthly average number of migraine days (MMD) during the 3-month double-blind period (DBP). Secondary endpoints included the proportion of participants achieving ≥50% reduction in MMD and change from baseline in monthly headache days of at least moderate severity (MHD).Results In total, 234 randomised participants (fremanezumab, n=123 [120 mg, n=36; 225 mg, n=87]; placebo, n=111) were included in the efficacy analysis. Fremanezumab significantly reduced MMD versus placebo (–2.5 vs –1.4; p=0.0210) during the DBP, with a ≥50% response rate of 47.2% versus 27.0% (p=0.0016). Reductions in MHD were significantly greater with fremanezumab versus placebo (–2.6 vs –1.5; p=0.0172).Conclusion These findings suggest that fremanezumab provides an effective preventive migraine treatment option in children and adolescents with EM.mark.fredericks@tevauk.com