Eptinezumab 100 mg and 300 mg met the primary endpoint, significantly reducing MMDs across weeks 1-12 compared with placebo (30 mg, -4.0 100 mg, -3.9, p = 0.0182 300 mg, -4.3 placebo, -3.2, p = 0.0001). Mean MMDs at baseline was ∼8.6 across treatment groups. The primary endpoint was change from baseline in monthly migraine days (MMDs) over weeks 1-12.Ī total of 888 patients received treatment across 84 study sites. Adults with episodic migraine were randomized to eptinezumab 30 mg, 100 mg, 300 mg, or placebo for up to four intravenous (IV) doses administered every 12 weeks. The PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy-1 (PROMISE-1) study was a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study.
To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of episodic migraine.
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