SPACE
(2026)Objective
To evaluate the efficacy and safety of fremanezumab (AJOVY) for preventive treatment of episodic migraine in children and adolescents ages 6-17 years
Study Summary
• Fremanezumab reduced monthly migraine days vs placebo in pediatric patients with episodic migraine
• Results contributed to FDA approval of AJOVY as first CGRP antagonist for pediatric migraine prevention
• Results contributed to FDA approval of AJOVY as first CGRP antagonist for pediatric migraine prevention
Intervention
Monthly injections of fremanezumab (AJOVY) - a calcitonin gene-related peptide (CGRP) antagonist
Inclusion Criteria
Children and adolescents ages 6-17 years with episodic migraine weighing ≥45 kg (99 lbs)
Study Design
Arms: Fremanezumab vs Placebo
Patients per Arm: 237 total enrolled (arm distribution not specified)
Outcome
• Fremanezumab reduced monthly migraine days by 2.5 days vs 1.4 days with placebo
• 47.2% of fremanezumab group achieved ≥50% reduction in monthly migraine days vs 27% placebo
• Led to FDA approval in August 2025 for pediatric use
• 47.2% of fremanezumab group achieved ≥50% reduction in monthly migraine days vs 27% placebo
• Led to FDA approval in August 2025 for pediatric use