A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Summary

The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to fremanezumab. The total duration of the study is planned to be up to 51 months.

Timeline

Start

2020-07-15

Primary completion

2024-03-13

Completion

2024-03-13

Outcome

Met primary endpoint

paper Fremanezumab reduced the number of migraine days per month by 2.5 as compared with 1.4 with placebo (difference, 1.1; P = 0.02) PMID 41534042 ↗

registry analysis (other test); Placebo vs Fremanezumab; p = 0.0210; LS mean Difference -1.0 (95% CI -1.90 to -0.16); ANCOVA NCT04458857 ↗

release “SPACE pediatric Phase 3 study met its primary end point for efficacy with a significantly greater reduction in Monthly Migraine Days compared to placebo” tevapharm.com ↗

Publications

• Hershey AD, Szperka CL, Barbanti P, Pozo-Rosich P, Bittigau P, Barash S, Bryson J, Kessler Y, Carmeli Schwartz Y, Ramirez Campos V, Ning X. Fremanezumab in Children and Adolescents with Episodic Migraine. N Engl J Med. 2026 Jan 15;394(3):243-252. doi: 10.1056/NEJMoa2504546.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fremanezumab	Monoclonal antibody	120 mg	Subcutaneous
Subject	Fremanezumab	Monoclonal antibody	225 mg	Subcutaneous

Indications