Four double-blind, placebo-controlled, randomized trials evaluated eptinezumab for the preventive treatment of migraine: NCT01772524 (EM, phase 2), NCT02559895 (EM, phase 3, PROMISE-1), NCT02275117 (CM, phase 2b), NCT02974153 (CM, phase 3, PROMISE-2). The percentage of patients experiencing a migraine (assessed using eDiary entries) was evaluated on Day 1, then as an averaged daily occurrence weekly through Week (Wk) 4; baseline was the average over the 28-day screening period.

In the EM trials, approximately 31% of patients experienced a migraine on any given day during the screening period. PROMISE-1: rates on Day 1 were 22.5% (placebo), 13.9% (300mg), 14.8% (100mg); 20.5%, 14.4%, 15.9% during Wk1; 20.5%, 15.8%, 17.1% during Wk4. NCT01772524: percentage of patients with a migraine on Day 1 was 13.7% (placebo) and 4.8% (1000mg); 18.4% and 9.8% during Wk1; 17.6% and 10.0% during Wk4.

In the CM trials, approximately 58%-59% of patients experienced a migraine on any given day during the screening period. PROMISE-2: rates on Day 1 were 42.3% (placebo), 27.8% (300mg), 28.6% (100mg); 40.6%, 28.8%, 31.3% during Wk1; 36.0%, 28.8%, 31.8% during Wk4. NCT02275117: percentage of patients with a migraine on Day 1 was 48.7% (placebo), 26.5% (300mg), 29.3% (100mg); 41.7%, 31.9%, 31.8% during Wk1; 41.0%, 30.1%, 30.2% during Wk4.

Across 4 migraine prevention trials, eptinezumab consistently demonstrated rapid onset of migraine preventive benefit beginning Day 1 after treatment and maintained weekly through Month 1.