Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1).

ABSTRACT: OBJECTIVE:To evaluate the efficacy and safety of eptinezumab, a humanized anti-calcitonin gene-related peptide monoclonal antibody, in the preventive treatment of episodic migraine. METHODS: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. 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 primary endpoint was change from baseline in monthly migraine days (MMDs) over weeks 1-12. RESULTS:A total of 888 patients received treatment across 84 study sites. Mean MMDs at baseline was ?8.6 across treatment groups. 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). Treatment-emergent adverse events were reported by 58.4% (30?mg), 63.2% (100?mg), 57.6% (300?mg), and 59.5% (placebo) of patients. Treatment-emergent adverse events reported by ?2% of eptinezumab-treated patients at an incidence greater than placebo included: upper respiratory tract infection (30?mg, 11.4%; 100?mg, 9.9%; 300?mg, 10.3%; placebo, 7.2%), and fatigue (30?mg, 2.3%; 100?mg, 3.6%; 300?mg, 3.6%; placebo, <1%). CONCLUSION:Eptinezumab (100?mg or 300?mg) significantly reduced migraine frequency, was well tolerated, and had an acceptable safety profile when used for the preventive treatment of migraine in adults with episodic migraine. ClinicalTrials.gov identifier: NCT02559895.

SUBMITTER: Ashina M 

PROVIDER: S-EPMC7066477 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature