2025 American Academy of Neurology Abstract Website

Andrew D. Hershey¹, Christina L. Szperka², Piero Barbanti³, Patricia Pozo-Rosich⁴, Petra Bittigau⁵, Steve Barash⁶, Sally Garnett⁶, Juline Bryson⁶, Yoel Kessler⁷, Yael Carmeli Schwartz⁷, Xiaoping Ning⁶
¹Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA, ²Children’s Hospital of Philadelphia and Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA, ³Headache and Pain Unit, IRCCS San Raffaele, Rome, Italy, and San Raffaele University, Rome, Italy, ⁴Headache Unit and Research Group, Vall d’Hebron Hospital and Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain, ⁵Charité-Universitätsmedizin Berlin, Berlin, Germany, ⁶Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA, ⁷Teva Pharmaceutical Industries Ltd., Tel Aviv, Israel

Objective:

The SPACE study (NCT04458857) evaluated the efficacy, safety, and tolerability of fremanezumab in children and adolescents with episodic migraine (EM).

Background:

Fremanezumab is a calcitonin gene-related peptide pathway monoclonal antibody approved for preventive migraine treatment in adults.

Design/Methods:

In this multicenter, double-blind, parallel-group, Phase 3 study, participants aged 6–17 years, with a migraine diagnosis for ≥6 months and history of ≤14 headache days/month, were randomized (1:1) to monthly fremanezumab (<45kg, 120 mg; ≥45kg, 225 mg) or placebo for 12 weeks. Primary endpoint: least-squares (LS) mean change from baseline in average monthly migraine days (MMD) during the double-blind period. Secondary endpoints included LS mean change from baseline in monthly headache days of at least moderate severity (MHD) and proportion of participants achieving a ≥50% reduction in MMD. Subgroup analyses were conducted by age (6–11 and 12–17 years) and sex.

Results:

Of 237 randomized participants, 234 (6–11 years, n=63; 12–17 years, n=171; male, n=105; female, n=129) were included in the efficacy analysis (fremanezumab, n=123; placebo, n=111). Fremanezumab significantly reduced MMD versus placebo (–2.5 vs –1.4; p=0.0210) over 3 months. LS mean changes from baseline in MMD favored fremanezumab over placebo in subgroups stratified by age (6–11 years: –3.4 vs –1.7; 12–17 years: –2.7 vs –1.8) and sex (male: –3.5 vs –2.2; female: –2.3 vs –1.5). The reduction in MHD was significantly greater with fremanezumab versus placebo (–2.6 vs –1.5; p=0.0172), as was the 50% response rate (47.2% vs 27.0%; p=0.0016). The proportion of participants reporting ≥1 adverse event (AE) was similar across treatment groups (fremanezumab, 55%; placebo, 49%). The proportion of participants with serious AEs (≤3%) and AEs leading to discontinuation (<1%) were low.

Conclusions:

These findings demonstrate the efficacy, safety, and tolerability of fremanezumab in children and adolescents with EM.