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The Migraine-Specific Quality-of-Life Questionnaire v2.1 (MSQv2.1) measured the impact of migraine on patient functioning. The Migraine Disability Assessment (MIDAS) quantified headache-related disability. Changes from baseline were analyzed with mixed model repeated measures or analysis of covariance.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Total MSQ score at baseline was 44.88\u2009\u00b1\u200918.02 (mean\u2009\u00b1\u2009SD), indicating significant functional impairment. At Month 3, least squares (LS) mean change\u2009\u00b1\u2009SE in total MSQ for galcanezumab-treated patients were 20.51\u2009\u00b1\u20091.49 (120\u00a0mg) and 20.49\u2009\u00b1\u20091.49 (240\u00a0mg), both statistically significantly greater vs placebo-treated patients (14.55\u2009\u00b1\u20091.21; both\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001). Total MIDAS score at baseline was 67.24\u2009\u00b1\u200957.31 (mean\u2009\u00b1\u2009SD). At Month 3, LS mean change\u2009\u00b1\u2009SE from baseline in total MIDAS for galcanezumab-treated patients was statistically significantly greater than placebo for 120\u00a0mg group (placebo:\u2009\u2212\u200911.53\u2009\u00b1\u20093.38 vs 120\u00a0mg:\u2009\u2212\u200920.27\u2009\u00b1\u20094.07;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.05) but not for 240\u00a0mg group (\u2212\u200917.02\u2009\u00b1\u20094.05). At Month 12, within-group mean changes from baseline for total MSQ (28.56\u2009\u00b1\u20091.19 previous placebo; 29.53\u2009\u00b1\u20091.51 previous 120\u00a0mg; 25.83\u2009\u00b1\u20091.49 previous 240\u00a0mg) and MIDAS scores (\u2212\u200928.47\u2009\u00b1\u20092.95 previous placebo;\u2009\u2212\u200931.47\u2009\u00b1\u20093.69 previous 120\u00a0mg;\u2009\u2212\u200931.13\u2009\u00b1\u20093.62 previous 240\u00a0mg) were statistically significant (\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u20090.001) for the open-label treatment population regardless of previous double-blind treatment assignment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Galcanezumab-treated patients with chronic migraine reported statistically significant improvements in functioning and disability, representing a clinically significant change.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>\n                      <jats:bold>\n                        <jats:italic>Trial registration<\/jats:italic>\n                      <\/jats:bold>\n                    <\/jats:title>\n                    <jats:p>ClinicalTrials.gov registry: NCT02614261. Registered 25 November 2015.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11136-020-02623-1","type":"journal-article","created":{"date-parts":[[2020,9,15]],"date-time":"2020-09-15T11:04:02Z","timestamp":1600167842000},"page":"105-115","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN)"],"prefix":"10.1007","volume":"30","clinical-trial-number":[{"clinical-trial-number":"nct02614261","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Janet","family":"Ford","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Tassorelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Leroux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shufang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Ayer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Russell","family":"Nichols","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holland","family":"Detke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,9,15]]},"reference":[{"key":"2623_CR1","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1111\/head.12999","volume":"57","author":"SK Aurora","year":"2017","unstructured":"Aurora, S. 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CT has consulted for Allergan S.p.A., electroCore, Inc., Eli Lilly and Company, Novartis AG, and Teva Neuroscience and is also a principal investigator or collaborator for randomized controlled trials sponsored by Alder BioPharmaceuticals Inc., Eli Lilly and Company, Novartis, and Teva Pharmaceutical Industries Ltd. EL has consulted for Allergan, Aralez, Eli Lilly and Company, Novartis AG, and Teva Neuroscience.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interest"}},{"value":"The study protocol was reviewed and approved by appropriate institutional review boards at each study site and was conducted according to Good Clinical Practice and the Declaration of Helsinki.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Patients provided written informed consent before initiating study procedures.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}