{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T21:43:30Z","timestamp":1792619010637,"version":"4.5.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2019,5,28]],"date-time":"2019-05-28T00:00:00Z","timestamp":1559001600000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009210","name":"Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009210","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Lasmiditan, a serotonin 5-HT1F receptor agonist, was effective for acute treatment of patients with migraine in a phase 3 double-blind randomized controlled study. The current study was designed to replicate these findings in a generalizable population of patients with migraine, including those with a cardiovascular medical history. This prospective, double-blind, phase 3 multicentre study randomly assigned patients with migraine with and without aura (1:1:1:1 ratio) to oral lasmiditan 200 mg, 100 mg, 50 mg, or placebo. Patients were instructed to dose at home within 4 h of onset of migraine attack of at least moderate intensity and not improving. The primary objective was to assess the proportion of patients\u2019 headache pain-free and most bothersome symptom-free at 2 h post-dose for each dose of lasmiditan versus placebo (NCT02605174). Patients (n = 3005) were assigned and treated (n = 2583, safety population): 1938 lasmiditan (200 mg n = 528, 100 mg n = 532, and 50 mg n = 556 included in primary analysis) and 645 placebo (540 included in primary analysis). Most patients (79.2%) had \u22651 cardiovascular risk factor at baseline, in addition to migraine. Lasmiditan was associated with significantly more pain freedom at 2 h (lasmiditan 200 mg: 38.8%, odds ratio 2.3, 95% confidence interval 1.8\u20133.1, P &lt; 0.001; 100 mg: 31.4%, odds ratio 1.7, 1.3\u20132.2, P &lt; 0.001; 50 mg: 28.6%, odds ratio 1.5, 1.1\u20131.9, P = 0.003 versus placebo 21.3%) and freedom from most bothersome symptom at 2 h (lasmiditan 200 mg: 48.7%, odds ratio 1.9, 95% confidence interval 1.4\u20132.4, P &lt; 0.001; 100 mg: 44.2%, odds ratio 1.6, 1.2\u20132.0, P &lt; 0.001; 50 mg: 40.8%, odds ratio 1.4, 1.1\u20131.8, P = 0.009 versus placebo 33.5%). Treatment-emergent adverse events were reported in 253 of 649 (39.0%), 229 of 635 (36.1%), and 166 of 654 (25.4%) of patients on lasmiditan 200, 100, and 50 mg, respectively, versus 75 of 645 (11.6%) on placebo. Most adverse events were CNS-related and included dizziness, somnolence and paraesthesia. Lasmiditan was effective at 2 h post-dose for acute treatment of migraine at all oral doses tested. Efficacy and safety were consistent with the previous phase 3 study.<\/jats:p>","DOI":"10.1093\/brain\/awz134","type":"journal-article","created":{"date-parts":[[2019,5,2]],"date-time":"2019-05-02T15:12:49Z","timestamp":1556809969000},"page":"1894-1904","source":"Crossref","is-referenced-by-count":251,"title":["Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine"],"prefix":"10.1093","volume":"142","author":[{"given":"Peter J","family":"Goadsby","sequence":"first","affiliation":[{"name":"NIHR-Wellcome Trust King\u2019s Clinical Research Facility, King\u2019s College Hospital; SLaM Biomedical Research Centre, and King\u2019s College London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda A","family":"Wietecha","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ellen B","family":"Dennehy","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"},{"name":"Purdue University, Department of Psychological Sciences, West Lafayette, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernice","family":"Kuca","sequence":"additional","affiliation":[{"name":"CoLucid Pharmaceuticals, Inc., a wholly owned subsidiary of Eli Lilly and Company, Cambridge, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael G","family":"Case","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheena K","family":"Aurora","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charly","family":"Gaul","sequence":"additional","affiliation":[{"name":"Migraine and 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