{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T10:11:18Z","timestamp":1792059078356,"version":"4.4.0"},"reference-count":27,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2023,1,18]],"date-time":"2023-01-18T00:00:00Z","timestamp":1674000000000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess long\u2010term safety, tolerability, and efficacy of once\u2010daily oral atogepant 60\u2009mg in adults with migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Atogepant is an oral, small\u2010molecule, calcitonin gene\u2013related peptide receptor antagonist approved for the preventive treatment of episodic migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A 52\u2010week, multicenter, randomized, open\u2010label trial of adults (18\u201380\u2009years) with migraine. Lead\u2010in trial completers or newly enrolled participants with 4\u201314 migraine days\/month were enrolled and randomized (5:2) to atogepant 60\u2009mg once daily or oral standard care (SC) migraine preventive medication. The primary objective was to evaluate the safety and tolerability of atogepant; safety assessments included treatment\u2010emergent adverse events (TEAEs), clinical laboratory evaluations, vital signs, and Columbia\u2010Suicide Severity Rating Scale scores. Efficacy assessments (atogepant only) included change from baseline in mean monthly migraine days (MMDs) and the proportion of participants with reductions from baseline of \u226550%, \u226575%, and 100% in MMDs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The trial included 744 participants randomized to atogepant 60\u2009mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u2009546) or SC (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u2009198). The atogepant safety population was 88.2% female (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u2009479\/543) with a mean (standard deviation) age of 42.5 (12.0) years. TEAEs occurred in 67.0% (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u2009364\/543) of participants treated with atogepant 60\u2009mg. The most commonly reported TEAEs (\u22655%) were upper respiratory tract infection (10.3%; 56\/543), constipation (7.2%; 39\/543), nausea (6.3%; 34\/543), and urinary tract infection (5.2%; 28\/543). Serious TEAEs were reported in 4.4% (24\/543) for atogepant. Mean (standard error) change in MMDs for atogepant was \u22123.8 (0.1) for weeks 1\u20134 and\u2009\u22125.2 (0.2) at weeks 49\u201352. Similarly, the proportion of participants with \u226550%, \u226575%, and 100% reductions in MMDs increased from 60.4% (310\/513), 37.2% (191\/513), and 20.7% (106\/513) at weeks 1\u20134 to 84.2% (282\/335), 69.9% (234\/335), and 48.4% (162\/335), at weeks 49\u201352.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Daily use of oral atogepant 60\u2009mg for preventive treatment of migraine during this 1\u2010year, open\u2010label trial was safe, well tolerated, and efficacious.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14439","type":"journal-article","created":{"date-parts":[[2023,1,18]],"date-time":"2023-01-18T06:55:40Z","timestamp":1674024940000},"page":"79-88","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":57,"title":["Once\u2010daily oral atogepant for the long\u2010term preventive treatment of migraine: Findings from a multicenter, randomized, open\u2010label, phase 3 trial"],"prefix":"10.1111","volume":"63","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0951-5804","authenticated-orcid":false,"given":"Messoud","family":"Ashina","sequence":"first","affiliation":[{"name":"Danish Headache Center, Department of Neurology Rigshospitalet Glostrup Faculty of Health and Medical Sciences, University of Copenhagen  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stewart J.","family":"Tepper","sequence":"additional","affiliation":[{"name":"Department of Neurology Geisel School of Medicine at Dartmouth  Hanover New\u00a0Hampshire USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Reuter","sequence":"additional","affiliation":[{"name":"Department of Neurology Charit\u00e9 Universit\u00e4tsmedizin Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew M.","family":"Blumenfeld","sequence":"additional","affiliation":[{"name":"Headache Center of Southern California  Carlsbad California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6353-2846","authenticated-orcid":false,"given":"Susan","family":"Hutchinson","sequence":"additional","affiliation":[{"name":"Orange County Migraine and Headache Center  Irvine California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Xia","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Miceli","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Severt","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Finnegan","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel M.","family":"Trugman","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,1,18]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1915327"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32160-7"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-016-0599-8"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-017-0787-1"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12047"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-5-56"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13456"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32342-4"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32162-0"},{"key":"e_1_2_12_12_1","unstructured":"EMGALITY (Galcanezumab\u2010gnim) injection [package insert].Eli Lilly and Company;2019."},{"key":"e_1_2_12_13_1","unstructured":"AIMOVIG (Erenumab\u2010aooe) [package insert].Amgen Inc.;2020."},{"key":"e_1_2_12_14_1","unstructured":"AJOVY (Fremanezumab\u2010vfrm) injection [package insert].Teva Pharmaceuticals USA Inc.;2020."},{"key":"e_1_2_12_15_1","unstructured":"VYEPTI (Eptinezumab\u2010jjmr) injection [package insert].Lundbeck Seattle BioPharmaceuticals Inc.;2020."},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13951"},{"key":"e_1_2_12_17_1","unstructured":"FDA approves QULIPTA (Atogepant) the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine[press release].AbbVie Inc.;2021."},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30234-9"},{"issue":"1","key":"e_1_2_12_19_1","first-page":"15","article-title":"Atogepant significantly reduces mean monthly migraine days in the 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The Journal of Head and Face 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