Preventive medication is recommended for EM patients with ≥4 headache days per month. Fremanezumab, a fully humanized monoclonal antibody (IgG2Δa) that selectively targets calcitonin gene-related peptide (CGRP), is efficacious in preventing EM, but its effectiveness in patients who failed previous preventive medications is unknown.

In this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, patients were randomized 1:1:1 to receive subcutaneous fremanezumab quarterly (675 mg at baseline and placebo at Weeks 4 and 8), fremanezumab monthly (225 mg at baseline, Weeks 4 and 8), or placebo (at baseline, Weeks 4 and 8). Analyses were performed in patients who failed at least one prior preventive migraine medication (due to lack of efficacy or intolerability). Endpoints included the proportion of patients with ≥50% reduction in the monthly average number of migraine days, mean change from baseline in the monthly average number of days of acute headache medication use or the Migraine Disability Assessment (MIDAS) score during the 12-week treatment period.