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Here, we analyze data from 3 randomized clinical trials (2 episodic trials [EVOLVE-1, EVOLVE-2] and 1 chronic trial [REGAIN]), to examine if galcanezumab also alleviates the severity and symptoms of migraine.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>The episodic migraine trials were 6-month, double-blind studies in patients with episodic migraine (4\u201314 monthly migraine headache days). The chronic migraine trial was a 3-month, double-blind study in patients with chronic migraine (\u2265\u200915 headache days per month, where \u2265\u20098 met criteria for migraine). Patients (18\u201365\u00a0years) were randomized to placebo or galcanezumab 120\u00a0mg with a 240-mg loading dose or 240\u00a0mg. Patients recorded headache characteristics, duration, severity, and presence of associated symptoms with each headache. The outcomes analyzed were changes from baseline in number of monthly migraine headache days with nausea and\/or vomiting, photophobia and phonophobia, aura, and prodromal symptoms other than aura. Additional outcomes analyzed included the number of moderate-to-severe monthly migraine headache days, number of severe migraine headache days, and mean severity of remaining migraine headache days. Change from baseline in the proportion of days with nausea and\/or vomiting and the proportion of days with photophobia and phonophobia among the remaining monthly migraine headache days were also analyzed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Galcanezumab was superior to placebo in reducing the frequency of migraine headache days with associated symptoms of migraine such as nausea and\/or vomiting, photophobia and phonophobia, and prodromal symptoms. Galcanezumab reduced the frequency of migraine headache days with aura in the episodic migraine studies. There was a significant reduction in the proportion of remaining migraine headache days with nausea and\/or vomiting for the episodic and chronic migraine studies, and with photophobia and phonophobia for the episodic migraine studies. Galcanezumab was superior to placebo in reducing the number of monthly moderate-to-severe migraine headache days and the overall and monthly severe migraine headache days.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Galcanezumab reduces the frequency of migraine headache days and can alleviate potentially disabling non-pain symptoms on days when migraine is present in patients with episodic or chronic migraine.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>NCT,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02614183\">NCT02614183<\/jats:ext-link>(EVOLVE-1), registered 25 November 2015; NCT,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02614196\">NCT02614196<\/jats:ext-link>, (EVOLVE-2), registered 25 November 2015; NCT,<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02614261\">NCT02614261<\/jats:ext-link>(REGAIN), registered 25 November 2015.<\/jats:p><\/jats:sec>","DOI":"10.1186\/s10194-021-01215-9","type":"journal-article","created":{"date-parts":[[2021,2,8]],"date-time":"2021-02-08T21:16:30Z","timestamp":1612818990000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine"],"prefix":"10.1186","volume":"22","author":[{"given":"Michael","family":"Ament","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6234-0065","authenticated-orcid":false,"given":"Kathleen","family":"Day","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia L","family":"Stauffer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladimir","family":"Skljarevski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mallikarjuna","family":"Rettiganti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Pearlman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheena K.","family":"Aurora","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,2,6]]},"reference":[{"key":"1215_CR1","doi-asserted-by":"publisher","first-page":"1211","DOI":"10.1016\/S0140-6736(17)32154-2","volume":"390","author":"GBD 2016 Disease and Injury Incidence and Prevalence Collaborators","year":"2017","unstructured":"GBD 2016 Disease and Injury Incidence and Prevalence Collaborators (2017) Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990\u20132016: a systematic analysis for the Global Burden of Disease Study 2016. 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They were all conducted according to Good Clinical Practice and the Declaration of Helsinki guidelines. All patients gave written informed consent to participate in the study.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"KD, VLS, VS, MR, and EP are full time employees and minor stockholders of Eli Lilly and Company. SKA is a former employee of Eli Lilly and Company. MA is a consultant for Eli Lilly and Company, BioHaven, and Impel, and is on speaker bureaus for Allergan\/AbbVie, Amgen Inc., BioHaven Pharmaceuticals, electroCore Inc., Eli Lilly and Company, Alder\/Lundbeck, and Teva Pharmaceuticals Industries.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"6"}}