{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T22:44:24Z","timestamp":1783118664146,"version":"3.54.6"},"reference-count":21,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2023,1,1]],"date-time":"2023-01-01T00:00:00Z","timestamp":1672531200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie Inc.","doi-asserted-by":"crossref","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Atogepant is a United States Food and Drug Administration-approved oral calcitonin gene-related peptide receptor antagonist for the preventive treatment of episodic migraine. The study objective was to evaluate the long-term safety and tolerability of atogepant in participants who completed the phase 3 ADVANCE trial (NCT03777059).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This 40-week, open-label extension trial (NCT03939312) monitored safety in participants receiving oral atogepant 60\u2009mg once daily, followed by a four-week safety follow-up period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of the 685 participants taking at least one dose of atogepant, the treatment period was completed by 74.6% of participants with a mean (standard deviation) treatment duration of 233.6 (89.3) days. Treatment-emergent adverse events occurred in 62.5% of participants, with upper respiratory tract infection (5.5%), urinary tract infection (5.3%), nasopharyngitis (4.8%), sinusitis (3.6%), constipation (3.4%), and nausea (3.4%) occurring at \u22653%. Serious adverse events were observed in 3.4% of participants (none were treatment-related), and there were no deaths. Adverse events leading to discontinuation occurring at &gt;0.1% were nausea (0.4%) and abdominal pain, vomiting, weight decrease, dizziness, and migraine (0.3% each).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>These results are consistent with atogepant\u2019s known safety profile and support long-term use of atogepant 60\u2009mg once daily dosing as safe and well tolerated. ClinicalTrials.gov Registration Number: NCT03939312<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024221128250","type":"journal-article","created":{"date-parts":[[2023,1,9]],"date-time":"2023-01-09T03:29:00Z","timestamp":1673234940000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":21,"title":["Safety and tolerability results of atogepant for the preventive treatment of episodic migraine from a 40-week, open-label multicenter extension of the phase 3 ADVANCE trial"],"prefix":"10.1177","volume":"43","author":[{"given":"Brad C","family":"Klein","sequence":"first","affiliation":[{"name":"Abington Neurological Associates, Ltd., Abington, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Miceli","sequence":"additional","affiliation":[{"name":"AbbVie Inc., Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Severt","sequence":"additional","affiliation":[{"name":"AbbVie Inc., Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"McAllister","sequence":"additional","affiliation":[{"name":"New England Institute for Neurology & Headache, Stamford, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6105-9159","authenticated-orcid":false,"given":"Laszlo","family":"Mechtler","sequence":"additional","affiliation":[{"name":"DENT Neurologic Institute, Amherst, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"McVige","sequence":"additional","affiliation":[{"name":"DENT Neurologic Institute, Amherst, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Merle","family":"Diamond","sequence":"additional","affiliation":[{"name":"Diamond Headache Clinic, Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Marmura","sequence":"additional","affiliation":[{"name":"Jefferson Headache Center, Department of Neurology, Thomas Jefferson University, Philadelphia, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Guo","sequence":"additional","affiliation":[{"name":"AbbVie Inc., Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"Finnegan","sequence":"additional","affiliation":[{"name":"AbbVie Inc., Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel M","family":"Trugman","sequence":"additional","affiliation":[{"name":"AbbVie Inc., Madison, NJ, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2023,1,9]]},"reference":[{"key":"bibr1-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000002275"},{"key":"bibr2-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32154-2"},{"key":"bibr3-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-018-0846-2"},{"key":"bibr4-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1111\/head.12055"},{"key":"bibr5-03331024221128250","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2014.20.1.22"},{"key":"bibr6-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1111\/head.13657"},{"key":"bibr7-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1177\/03331024211018137"},{"key":"bibr8-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1111\/ene.14715"},{"key":"bibr9-03331024221128250","volume":"96","author":"Ashina M","year":"2021","journal-title":"Neurology"},{"key":"bibr10-03331024221128250","volume-title":"QULIPTA (package insert)","author":"AbbVie","year":"2021"},{"key":"bibr11-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30234-9"},{"key":"bibr12-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2035908"},{"key":"bibr13-03331024221128250","unstructured":"Food and Drug Administration. (2021) Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards. Available at: https:\/\/www.fda.gov\/media\/136238\/download (accessed 20 November 2021)."},{"key":"bibr14-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-0974-3"},{"key":"bibr15-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1016\/j.medidd.2020.100053"},{"key":"bibr16-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000010600"},{"key":"bibr17-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-018-1193-2"},{"key":"bibr18-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-021-02123-w"},{"key":"bibr19-03331024221128250","doi-asserted-by":"crossref","DOI":"10.1212\/WNL.96.15_supplement.2370","volume":"96","author":"Schim J","year":"2021","journal-title":"Neurology"},{"key":"bibr20-03331024221128250","doi-asserted-by":"publisher","DOI":"10.3389\/fphys.2018.01249"},{"key":"bibr21-03331024221128250","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-0979-y"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024221128250","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024221128250","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024221128250","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:45:20Z","timestamp":1777387520000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03331024221128250"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,1]]},"references-count":21,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2023,1]]}},"alternative-id":["10.1177\/03331024221128250"],"URL":"https:\/\/doi.org\/10.1177\/03331024221128250","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,1]]},"article-number":"03331024221128250"}}