SPACE - Fremanezumab Pediatric
(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 (≥45 kg)
• Results contributed to FDA approval of AJOVY as first CGRP antagonist for pediatric migraine prevention (≥45 kg)
Intervention
Monthly subcutaneous fremanezumab (AJOVY), a CGRP antagonist, dosed by weight: 120 mg for patients <45 kg and 225 mg for patients ≥45 kg, for 12 weeks
Inclusion Criteria
Children and adolescents ages 6-17 years with episodic migraine (history of migraine ≥6 months, ≤14 headache days/month)
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 (between-group difference −1.1 days, p=0.02)
• 47.2% of fremanezumab group achieved ≥50% reduction in monthly migraine days vs 27.0% placebo (p=0.002)
• Reduction in monthly moderate/severe headache days: −2.6 vs −1.5 (p=0.02)
• Adverse events similar (fremanezumab 55% vs placebo 49%); serious AEs ≤3%; discontinuations <1%
• Supported FDA approval in August 2025 for pediatric patients ≥45 kg
• 47.2% of fremanezumab group achieved ≥50% reduction in monthly migraine days vs 27.0% placebo (p=0.002)
• Reduction in monthly moderate/severe headache days: −2.6 vs −1.5 (p=0.02)
• Adverse events similar (fremanezumab 55% vs placebo 49%); serious AEs ≤3%; discontinuations <1%
• Supported FDA approval in August 2025 for pediatric patients ≥45 kg