{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T17:50:53Z","timestamp":1792605053825,"version":"4.5.0"},"reference-count":30,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T00:00:00Z","timestamp":1751241600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The objectives of this study were to compare the efficacy, including dose response, and safety of rimegepant, an orally administered small\u2010molecule calcitonin gene\u2010related peptide receptor antagonist, with placebo for the acute treatment of migraine in Japan.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>There is a substantial unmet need for the acute treatment of migraine in Japan due to undesirable attributes of existing acute treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this Phase 2\/3, double\u2010blind, randomized trial, adults with a \u22651\u2010year history of migraine were recruited to 50 study centers in Japan. Participants were randomly assigned to receive rimegepant 25\u2009mg, rimegepant 75\u2009mg, or placebo and instructed to treat a single migraine attack of moderate or severe pain intensity. The randomization was stratified by preventive migraine medication use (yes or no). The primary endpoint was the proportion of participants with pain freedom at 2\u2009h post\u2010dose. Formal hypothesis testing was conducted for rimegepant 75\u2009mg versus placebo. Safety was assessed based on adverse events (AEs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The study was conducted from August 9, 2022, through January 19, 2024. A total of 706 treated participants were evaluable for efficacy (rimegepant 25\u2009mg,\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u2009238; rimegepant 75\u2009mg,\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u2009238; placebo,\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u2009230) and safety (rimegepant 25\u2009mg,\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u2009239; rimegepant 75\u2009mg,\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u2009238; placebo,\n                      <jats:italic>n\u2009=<\/jats:italic>\n                      \u2009229). Response rates for pain freedom at 2\u2009h post\u2010dose were 21.0% (rimegepant 25\u2009mg), 32.4% (rimegepant 75\u2009mg), and 13.0% (placebo): percentage difference rimegepant 75\u2009mg versus placebo was\u00a019.4% (95% confidence interval 12.0\u201326.8%,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). On\u2010treatment AEs were reported by 7.1% (rimegepant 25\u2009mg), 9.2% (rimegepant 75\u2009mg), and 6.6% (placebo) of treated participants; all were mild or moderate in intensity and most were not considered related to the study drug.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Rimegepant 75\u2009mg demonstrated efficacy superior to placebo for the acute treatment of migraine, with a favorable safety profile, in participants in Japan. A dose\u2013response relationship was observed for rimegepant (NCT05399459).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Plain Language Summary<\/jats:title>\n                    <jats:p>This randomized trial was designed to test the effectiveness and safety of rimegepant for the acute treatment of migraine among adults in Japan. Results indicated that rimegepant was more effective than placebo, and the 75\u2009mg dose was observed to be more effective than the 25\u2009mg dose. These results are similar to previous findings from clinical studies in other countries, and suggest that rimegepant can help patients with migraine in Japan.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14994","type":"journal-article","created":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T08:11:17Z","timestamp":1751271077000},"page":"1811-1820","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Efficacy and safety of rimegepant for the acute treatment of migraine in Japan: A dose\u2010ranging, double\u2010blind, randomized controlled trial"],"prefix":"10.1111","volume":"65","author":[{"given":"Koichi","family":"Ikeda","sequence":"first","affiliation":[{"name":"Ikeda Neurosurgical Clinic  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiko","family":"Matsumori","sequence":"additional","affiliation":[{"name":"Sendai Headache and Neurology Clinic  Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masako","family":"Kudo","sequence":"additional","affiliation":[{"name":"Department of Neurology and Gerontology Iwate Medical University  Iwate Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0901-368X","authenticated-orcid":false,"given":"Tomofumi","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Pfizer R&amp;D Japan  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Hoshino","sequence":"additional","affiliation":[{"name":"Pfizer R&amp;D Japan  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Yoshimatsu","sequence":"additional","affiliation":[{"name":"Pfizer R&amp;D Japan  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Thiry","sequence":"additional","affiliation":[{"name":"Pfizer  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akio","family":"Arakawa","sequence":"additional","affiliation":[{"name":"Pfizer R&amp;D Japan  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Croop","sequence":"additional","affiliation":[{"name":"Biohaven Pharmaceuticals  New Haven Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terence","family":"Fullerton","sequence":"additional","affiliation":[{"name":"Pfizer  Groton Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumihiko","family":"Sakai","sequence":"additional","affiliation":[{"name":"Saitama International Headache Center Saitama Neuropsychiatric Institute  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Takeshima","sequence":"additional","affiliation":[{"name":"Headache Center, Department of Neurology Tominaga Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,6,30]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-022-00763-1"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.1997.1701015.x"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-020-01208-0"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-023-00569-3"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-023-01700-3"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-023-01619-9"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-022-02289-w"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-020-01848-4"},{"key":"e_1_2_13_11_1","volume-title":"Clinical practice guideline for headache disorders 2021","author":"Headache Clinical Practice Guideline Development Committee","year":"2021"},{"key":"e_1_2_13_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14153"},{"key":"e_1_2_13_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-021-00509-5"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-1012-1"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2021.1971179"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-024-01722-5"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/hup.2732"},{"key":"e_1_2_13_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1811090"},{"key":"e_1_2_13_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31606-X"},{"key":"e_1_2_13_20_1","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S453806"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(23)00126-6"},{"key":"e_1_2_13_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32544-7"},{"key":"e_1_2_13_23_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419828967"},{"key":"e_1_2_13_24_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413500727"},{"key":"e_1_2_13_25_1","volume-title":"Nurtec ODT (Rimegepant) Orally Disintegrating Tablets Prescribing Information","author":"Biohaven Pharmaceuticals","year":"2022"},{"key":"e_1_2_13_26_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001256"},{"key":"e_1_2_13_27_1","doi-asserted-by":"publisher","DOI":"10.1177\/03331024241232944"},{"key":"e_1_2_13_28_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420938655"},{"key":"e_1_2_13_29_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-023-00988-8"},{"key":"e_1_2_13_30_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2021.1895749"},{"key":"e_1_2_13_31_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419884943"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14994","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,22]],"date-time":"2025-11-22T04:41:47Z","timestamp":1763786507000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14994"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,6,30]]},"references-count":30,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1111\/head.14994"],"URL":"https:\/\/doi.org\/10.1111\/head.14994","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,30]]},"assertion":[{"value":"2024-11-28","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-06-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}