{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T07:13:33Z","timestamp":1791357213297,"version":"4.3.1"},"reference-count":15,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2019,6,5]],"date-time":"2019-06-05T00:00:00Z","timestamp":1559692800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2019,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      We assessed the safety profile of lasmiditan, a selective 5-HT\n                      <jats:sub>1F<\/jats:sub>\n                      receptor agonist without vasoconstrictive activity being developed as an acute therapy for migraine.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>SAMURAI and SPARTAN were Phase 3 double-blind studies of patients with migraine, randomized to oral lasmiditan 50\u2009mg (SPARTAN only), 100\u2009mg, 200\u2009mg, or placebo to be taken within 4 hours of onset of migraine pain. Safety data from the studies were integrated. Treatment-emergent adverse events (occurring within 48 hours of first dose) were considered in the analyses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The safety population comprised 1262 patients assigned placebo, and 654, 1265, and 1258 assigned lasmiditan 50\u2009mg, 100\u2009mg, and 200\u2009mg, respectively. There were no deaths; serious adverse events were reported for seven patients (placebo, n\u2009=\u20092 [0.2%]; lasmiditan 50\u2009mg, n\u2009=\u20091 [0.2%]; lasmiditan 100\u2009mg, n\u2009=\u20091 [0.2%]; lasmiditan 200\u2009mg, n\u2009=\u20093 [0.2%]). Patients reporting\u2009\u2265\u20091 treatment-emergent adverse events were: Placebo, n\u2009=\u2009174 (13.5%); lasmiditan 50\u2009mg, n\u2009=\u2009166 (25.4%); lasmiditan 100\u2009mg, n\u2009=\u2009458 (36.2%); and lasmiditan 200\u2009mg, n\u2009=\u2009510 (40.6%). Treatment-emergent adverse events were generally mild or moderate in severity. The most common treatment-emergent adverse events with lasmiditan were dizziness, paresthesia, somnolence, fatigue, nausea, muscular weakness and hypoesthesia. There were no ischemic events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>As a centrally-penetrant drug, lasmiditan use was associated with neurologic treatment-emergent adverse events; most were mild or moderate in severity and self-limiting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration at clinicaltrials.gov<\/jats:title>\n                    <jats:p>SAMURAI (NCT02439320) and SPARTAN (NCT02605174).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0333102419855080","type":"journal-article","created":{"date-parts":[[2019,6,5]],"date-time":"2019-06-05T12:34:06Z","timestamp":1559738046000},"page":"957-966","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":68,"title":["Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN"],"prefix":"10.1177","volume":"39","author":[{"given":"John H","family":"Krege","sequence":"first","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul B","family":"Rizzoli","sequence":"additional","affiliation":[{"name":"Brigham and Women's Faulkner Hospital, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily","family":"Liffick","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin G","family":"Doty","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherie A","family":"Dowsett","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianing","family":"Wang","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew S","family":"Buchanan","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, IN, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,6,5]]},"reference":[{"key":"bibr1-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1007\/s13311-018-0615-6"},{"key":"bibr2-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000006641"},{"key":"bibr3-0333102419855080","author":"Goadsby PJ LL","journal-title":"Brain"},{"key":"bibr5-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1161\/01.cir.0000437741.48606.98"},{"key":"bibr7-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1093\/qjmed\/hcg109"},{"key":"bibr8-0333102419855080","author":"Tepper SK","journal-title":"Headache"},{"key":"bibr9-0333102419855080","first-page":"24","volume":"29","author":"Pilgrim A","year":"2009","journal-title":"Cephalalgia"},{"key":"bibr10-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bjp.0702773"},{"key":"bibr11-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1016\/j.nurt.2010.03.003"},{"key":"bibr12-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2018.01.005"},{"key":"bibr13-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.j2099"},{"key":"bibr14-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2017-020498"},{"key":"bibr15-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-6632.1990.tb16912.x"},{"key":"bibr16-0333102419855080","doi-asserted-by":"publisher","DOI":"10.2174\/187152412803760627"},{"key":"bibr22-0333102419855080","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)06711-3"}],"updated-by":[{"DOI":"10.1177\/03331024211015848","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2021,5,5]],"date-time":"2021-05-05T00:00:00Z","timestamp":1620172800000}}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0333102419855080","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/0333102419855080","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/0333102419855080","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:48:19Z","timestamp":1777387699000},"score":1,"resource":{"primary":{"URL":"http:\/\/journals.sagepub.com\/doi\/10.1177\/0333102419855080"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,6,5]]},"references-count":15,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2019,7]]}},"alternative-id":["10.1177\/0333102419855080"],"URL":"https:\/\/doi.org\/10.1177\/0333102419855080","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,6,5]]}}}