Meeting a Growing Need for Specialized TAND Care
Despite migraine affecting millions of children and adolescents, preventive treatment options supported by strong pediatric evidence have historically been limited. Cincinnati Children's has played a leading role in advancing pediatric migraine research, and new findings published in The New England Journal of Medicine provide evidence supporting fremanezumab as a preventive treatment option for episodic migraine in children and adolescents. The study was led by Andrew D. Hershey, MD, PhD, FAAN, FAHS, Endowed Chair and Director of Neurology at Cincinnati Children's and principal investigator of the international SPACE trial.
Cincinnati Children's Research Supports New Pediatric Migraine Treatment Option
The phase 3 study enrolled 237 children and adolescents, ages 6 to 17 years, with episodic migraine across 89 sites in nine countries. Participants received monthly fremanezumab or placebo injections for three months.
Investigators found:
- Monthly migraine days decreased by 2.5 days with fremanezumab versus 1.4 days with placebo.
- The percentage of participants achieving at least a 50% reduction in migraine days was 47.2% among the fremanezumab group compared to 27% among the placebo group.
- The safety profile was consistent with prior adult studies, with no new safety signals identified.
The findings contributed to FDA approval of fremanezumab (AJOVY®) for the preventive treatment of episodic migraine in children and adolescents ages 6-17 years weighing at least 45 kilograms, making it the first approved CGRP-targeted therapy for this population.
