{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T15:59:40Z","timestamp":1787759980111,"version":"build-2784847793"},"reference-count":31,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,9,1]],"date-time":"2025-09-01T00:00:00Z","timestamp":1756684800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"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":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Atogepant is an oral calcitonin gene\u2013related peptide receptor antagonist approved in the US and EU for the preventive treatment of migraine in adults. We evaluated the efficacy, safety, and tolerability of atogepant for the preventive treatment of episodic migraine (EM) in Japanese participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>RELEASE was a phase 2\/3, multicenter, randomized, double-blind, placebo-controlled study enrolling adult participants with a \u22651-year history of migraine, &lt;50 years of age at time of migraine onset, history of 4\u201314 monthly migraine days (MMDs), and &lt;15 monthly headache days in the three months prior to screening and during the screening\/baseline period. The study included a four-week screening\/baseline period, 12-week double-blind treatment period (DBTP), 12-week active treatment extension period, and 30-day safety follow-up. Participants were randomized 1:1:1:1 to placebo, atogepant 10\u2005mg once daily (QD), 30\u2005mg QD, or 60\u2005mg QD for the 12-week DBTP. Completers of the DBTP could continue to the 12-week active treatment extension period where the placebo group was rerandomized 1:1:1 to atogepant 10\u2005mg, 30\u2005mg, or 60\u2005mg; atogepant groups continued the same dose. The primary endpoint was the change from baseline in mean MMDs across the 12-week DBTP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 807 participants screened, 523 were treated in the 12-week DBTP (Safety Population 1 [placebo, N\u2009=\u2009134; atogepant 10\u2005mg, N\u2009=\u2009126; 30\u2005mg, N\u2009=\u2009131; 60\u2005mg, N\u2009=\u2009132]; modified intent-to-treat population [placebo, N\u2009=\u2009133; atogepant 10\u2005mg, N\u2009=\u2009127; 30\u2005mg, N\u2009=\u2009130; 60\u2005mg, N\u2009=\u2009131]). The least square mean difference (95% confidence interval) from placebo in mean MMDs across 12 weeks was \u22121.57 (\u22122.24, \u22120.89) for atogepant 10\u2005mg, \u22121.90 (\u22122.57, \u22121.22) for 30\u2005mg, and \u22122.10 (\u22122.78, \u22121.43) for 60\u2005mg (all\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001). Treatment-emergent adverse events (TEAEs) in the DBTP occurred in 46.3%, 45.2%, 38.9%, and 43.2% of participants receiving placebo, atogepant 10\u2005mg, 30\u2005mg and 60\u2005mg, respectively. During the DBTP, TEAEs occurring \u22655% were constipation and nasopharyngitis, and there was one serious TEAE in the atogepant 10\u2005mg group considered not related to treatment. TEAEs resulting in treatment discontinuation were infrequent in all treatment groups in the DBTP. Safety was consistent in the 12-week active treatment extension period.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Atogepant treatment demonstrated statistically significant and clinically meaningful reductions in mean MMDs compared with placebo across the 12-week DBTP in Japanese participants with EM. The safety profile of atogepant in Japanese participants was consistent with the known safety profile in the global population. No new safety signals were identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov NCT05861427;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05861427\">https:\/\/clinicaltrials.gov\/study\/NCT05861427<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024251374569","type":"journal-article","created":{"date-parts":[[2025,9,26]],"date-time":"2025-09-26T13:12:32Z","timestamp":1758892352000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Atogepant for the preventive treatment of episodic migraine in Japanese participants: A phase 2\/3, randomized, double-blind, placebo-controlled trial with an active treatment extension (RELEASE)"],"prefix":"10.1177","volume":"45","author":[{"given":"Yasuhiko","family":"Matsumori","sequence":"first","affiliation":[{"name":"Sendai Headache and Neurology Clinic, Sendai, Miyagi, \rJapan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Yamada","sequence":"additional","affiliation":[{"name":"Umenotsuji Clinic, Kochi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshishige","family":"Nagaseki","sequence":"additional","affiliation":[{"name":"Nagaseki Headache Clinic, Yamanashi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazutaka","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Tokyo Headache Clinic, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-8698-941X","authenticated-orcid":false,"given":"Krisztian","family":"Nagy","sequence":"additional","affiliation":[{"name":"AbbVie, North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryotaro","family":"Matsuzawa","sequence":"additional","affiliation":[{"name":"AbbVie GK, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Otani","sequence":"additional","affiliation":[{"name":"AbbVie GK, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Molly Yizeng","family":"He","sequence":"additional","affiliation":[{"name":"AbbVie, North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Guo","sequence":"additional","affiliation":[{"name":"AbbVie, North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9235-2876","authenticated-orcid":false,"given":"Gina","family":"Ahmadyar","sequence":"additional","affiliation":[{"name":"AbbVie, North Chicago, IL, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Takeshima","sequence":"additional","affiliation":[{"name":"Headache Center and Department of Neurology, Tominaga Hospital, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,9,26]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.14153"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.1997.1701015.x"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(24)00038-3"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2004.04004.x"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1097\/j.pain.0000000000002275"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-020-01208-0"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420919098"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.12878"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1177\/0333102410381145"},{"key":"e_1_3_3_12_2","unstructured":"Araki N Tagao T Igarashi H et al. 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