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This report describes the results of PROMISE-2 through 24\u2009weeks of treatment.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>Patients received up to two 30-min IV administrations of eptinezumab 100\u2009mg, 300\u2009mg, or placebo separated by 12\u2009weeks. Patients recorded migraine and headache endpoints in a daily eDiary. Additional assessments, including patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 32-week study period (screening, day 0, and weeks 2, 4, 8, 12, 16, 20, 24, and 32).<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>A total of 1072 adults received treatment: eptinezumab 100\u2009mg, <jats:italic>n<\/jats:italic>\u2009=\u2009356; eptinezumab 300\u2009mg, <jats:italic>n<\/jats:italic>\u2009=\u2009350; placebo, <jats:italic>n<\/jats:italic>\u2009=\u2009366. The reduction in mean monthly migraine days observed during the first dosing interval (100\u2009mg, \u2212\u20097.7\u2009days; 300\u2009mg, \u2212\u20098.2\u2009days; placebo, \u2212\u20095.6\u2009days) was further decreased after an additional dose (100\u2009mg, \u2212\u20098.2\u2009days; 300\u2009mg, \u2212\u20098.8\u2009days; placebo, \u2212\u20096.2\u2009days), with both doses of eptinezumab demonstrating consistently greater reductions from baseline compared to placebo. The \u226550% and\u2009\u2265\u200975% migraine responder rates (MRRs) increased after a second dose, with more eptinezumab-treated patients experiencing migraine response than placebo patients (\u226550% MRRs weeks 13\u201324: 100\u2009mg, 61.0%; 300\u2009mg, 64.0%; placebo, 44.0%; and\u2009\u2265\u200975% MRRs weeks 13\u201324: 100\u2009mg, 39.3%; 300\u2009mg, 43.1%; placebo, 23.8%). The percentages of patients who improved on patient-reported outcomes, including the Headache Impact Test and Patient Global Impression of Change, increased following the second dose administration at week 12, and were greater with eptinezumab than with placebo at all time points. No new safety concerns were identified with the second dose regarding the incidence, nature, and severity of treatment-emergent adverse events.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Eptinezumab 100\u2009mg or 300\u2009mg administered IV at day 0 and repeated at week 12 provided sustained migraine preventive benefit over a full 24\u2009weeks and demonstrated an acceptable safety profile in patients with chronic migraine.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ClinicalTrials.gov (Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02974153\">NCT02974153<\/jats:ext-link>). Registered November 23, 2016.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s10194-020-01186-3","type":"journal-article","created":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T21:03:04Z","timestamp":1602018184000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":86,"title":["Eptinezumab for the prevention of chronic migraine: efficacy and safety through 24\u2009weeks of treatment in the phase 3 PROMISE-2 (Prevention of migraine via intravenous ALD403 safety and efficacy\u20132) study"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9467-5567","authenticated-orcid":false,"given":"Stephen","family":"Silberstein","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merle","family":"Diamond","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nada A.","family":"Hindiyeh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Biondi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roger","family":"Cady","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joe","family":"Hirman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brent","family":"Allan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Pederson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Schaeffler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,10,6]]},"reference":[{"key":"1186_CR1","doi-asserted-by":"publisher","unstructured":"Headache Classification Committee of the International Headache Society (IHS). 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All clinical work was conducted in compliance with current Good Clinical Practices as referenced in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines, local regulatory requirements, and the principles of the Declaration of Helsinki. All patients enrolled in the study provided written informed consent prior to their participation.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"SS: Receives or has received, as a consultant and\/or advisory panel member, honoraria from Allergan, Amgen, Avanir Pharmaceuticals, Cefaly, Curelator, Dr. Reddy\u2019s Laboratories, Egalet Corporation, electroCore Medical, eNeura, Lilly USA, Lundbeck Seattle Biopharmaceuticals, Medscape, National Institute of Neurological Disorders and Stroke, Satsuma Pharmaceuticals, Supernus Pharmaceuticals, Teva Pharmaceuticals, Theranica, and Trigemina, and reports consulting fees from Alder, Allergan, Amgen, Avanir, Curelator, Dr. Reddy\u2019s Laboratories, electroCore, Eli Lilly, eNeura, Medscape, National Institute of Neurological Disorders and Stroke, Supernus, Teva, Theranica, and Trigemina.MD: Advisory boards and a consultant for Amgen, Lundbeck Seattle Biopharmaceuticals, Promius Pharma, Teva Pharmaceutical Industries; advisory boards for Avanir Pharmaceuticals, Depomed, Eli Lilly, Supernus Pharmaceuticals, Upsher-Smith Laboratories; speakers\u2019 bureaus for Amgen, Avanir Pharmaceuticals, Depomed, Pernix Therapeutics, Supernus Pharmaceuticals, Teva Pharmaceutical Industries; Board of Directors for the National Headache Foundation and the Diamond Headache Clinic Research and Educational Foundation.NAH: Serves on speaker\u2019s bureaus for Amgen, Eli Lilly, and electroCore, and serves on advisory boards for Amgen, Eli Lilly, Lundbeck Chicago Biopharmaceuticals, and Zosano Pharma.DB: Full-time employee of Alder BioPharmaceuticals (currently known as Lundbeck Seattle BioPharmaceuticals) at the time of the study; Contracted service provider during manuscript development.RC: Full-time employee of Lundbeck Seattle BioPharmaceuticals.JH: Contracted service provider of biostatistical resources to Lundbeck Seattle BioPharmaceuticals.BA: Full-time employee of Alder BioPharmaceuticals (currently known as Lundbeck Seattle BioPharmaceuticals) at the time of the study; Contracted service provider during manuscript development.SP: Full-time employee of Lundbeck Seattle BioPharmaceuticals.BS: Full-time employee of Lundbeck Seattle BioPharmaceuticals at the time of the study and during manuscript development.JS: Full-time employee of Alder BioPharmaceuticals (currently known as Lundbeck Seattle BioPharmaceuticals) at the time of the study; Contracted service provider during manuscript development.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"120"}}