{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:34:35Z","timestamp":1790620475486,"version":"4.1.0"},"reference-count":21,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T00:00:00Z","timestamp":1621036800000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2021,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of lasmiditan in Japanese adults with migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Global clinical studies have demonstrated the efficacy and safety of lasmiditan in the acute treatment of migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a multicenter, randomized, double\u2010blind, placebo\u2010controlled, phase 2 study in Japan (NCT03962738), which enrolled adults with migraine with or without aura. Participants were randomized 7:3:7:6 to placebo, lasmiditan 50\u00a0mg, 100\u00a0mg, or 200\u00a0mg to be self\u2010administered orally within 4\u00a0h of onset of a single moderate\u2010to\u2010severe migraine attack. Participants recorded their response to treatment prior to dosing and for 48\u00a0h postdose. The primary endpoint was headache pain freedom at 2\u00a0h postdose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Participants (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0846) were randomized and treated (\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0691, safety;\n                      <jats:italic>N<\/jats:italic>\n                      \u00a0=\u00a0682, modified intent\u2010to\u2010treat). At 2\u00a0h postdose, a significantly higher proportion of participants were headache pain\u2010free in the lasmiditan 200\u00a0mg (40.8%, 73\/179; odds ratio 3.46 [95% confidence interval 2.17 to 5.54];\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.001; primary objective) and 100\u00a0mg groups (32.4%, 67\/207; odds ratio 2.41 [1.51 to 3.83];\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.001) compared with the placebo group (16.6%, 35\/211), whereas the lasmiditan 50 mg group had a numerically higher proportion of participants headache pain\u2010free (23.5%, 20\/85; odds ratio 1.55 [0.83 to 2.87];\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.167) compared with placebo. A statistically significant linear dose\u2013response relationship for pain freedom was achieved at 2\u00a0h by a Cochran\u2013Armitage trend test (\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0&lt;\u00a00.001). Lasmiditan treatment was also associated with headache pain relief, most bothersome symptom freedom, and improvement on disability and Patient Global Impression of Change outcomes. The majority of treatment\u2010emergent adverse events were mild and of short duration, the most common of which were dizziness (39.4%; 188\/477), somnolence (19.3%; 92\/477), and malaise (10.5%; 50\/477) in all lasmiditan groups, with no serious adverse events reported.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Lasmiditan was well tolerated and effective for the acute treatment of Japanese patients with migraine, consistent with global phase 3 studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14122","type":"journal-article","created":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T04:54:50Z","timestamp":1621054490000},"page":"755-765","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":37,"title":["Phase 2 randomized placebo\u2010controlled study of lasmiditan for the acute treatment of migraine in Japanese patients"],"prefix":"10.1111","volume":"61","author":[{"given":"Fumihiko","family":"Sakai","sequence":"first","affiliation":[{"name":"Saitama International Headache Center Saitama Neuropsychiatric Institute Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Takeshima","sequence":"additional","affiliation":[{"name":"Department of Neurology Tominaga Hospital Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6854-5627","authenticated-orcid":false,"given":"Gosuke","family":"Homma","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuka","family":"Tanji","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideaki","family":"Katagiri","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mika","family":"Komori","sequence":"additional","affiliation":[{"name":"Eli Lilly Japan K.K. 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