{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T17:26:27Z","timestamp":1785000387917,"version":"3.55.0"},"reference-count":33,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2023,2,16]],"date-time":"2023-02-16T00:00:00Z","timestamp":1676505600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"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":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate changes in interictal burden with galcanezumab versus placebo in patients with episodic (EM) or chronic migraine (CM).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The disruptive effects of migraine occur both during attacks (ictal period) and between attacks (interictal period), affecting work, school, family, and social life. Migraine clinical trials typically assess ictal burden endpoints, neglecting interictal burden.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      CONQUER was a 3\u2010month, double\u2010blind study that randomized adult patients with EM or CM who had experienced failure of two to four standard\u2010of\u2010care migraine preventive medication categories to receive monthly galcanezumab (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0232) or placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a0230), followed by 3\u2009months of open\u2010label galcanezumab. The mean change in interictal burden, a secondary objective, was measured using the four\u2010item Migraine Interictal Burden Scale (MIBS\u20104). The total score for MIBS\u20104 can range from zero to 12, with scores \u22655 indicating severe interictal burden. Post hoc analyses evaluated shifts in MIBS\u20104 severity categories and item\u2010level improvement.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The MIBS\u20104 total score indicated severe interictal burden at baseline (mean [SD]: all patients, 5.5 [3.5]; EM, 5.0 [3.4]; CM, 6.2 [3.5]). Reductions in the MIBS\u20104 score were significantly greater with galcanezumab versus placebo at Month 3 (mean [SE]: all patients \u22121.9 [0.2] vs. \u22120.8 [0.2],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.0001; EM, \u22121.8 [0.3] vs. \u22121.1 [0.3],\n                      <jats:italic>p<\/jats:italic>\n                      \u00a0=\u00a00.033; CM, \u22121.8 [0.4] vs. \u22120.3 [0.4],\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001), with further improvement at Month 6 after all patients had received galcanezumab (mean [SE]: all patients, \u22122.4 [0.2] vs. \u22122.0 [0.2]; EM, \u22122.3 [0.3] vs. \u22122.2 [0.3]; CM, \u22122.1 [0.4] vs. \u22121.5 [0.4]). The percentage of patients with severe interictal burden decreased substantially for the galcanezumab\u2010treated patients, from 59% (137\/232) at baseline to 27% (58\/217) at Month 6 (EM from 51% [70\/137] to 23% [30\/131]; CM from 71% [67\/95] to 33% [28\/86]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In addition to the known efficacy of galcanezumab in the ictal period, these findings suggest treatment with galcanezumab results in a significant reduction in interictal burden.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14460","type":"journal-article","created":{"date-parts":[[2023,2,16]],"date-time":"2023-02-16T23:00:45Z","timestamp":1676588445000},"page":"683-691","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Changes in migraine interictal burden following treatment with galcanezumab: Results from a phase III randomized, placebo\u2010controlled study"],"prefix":"10.1111","volume":"63","author":[{"given":"Richard B.","family":"Lipton","sequence":"first","affiliation":[{"name":"The Saul R. 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Korey Department of Neurology Albert Einstein College of Medicine of Yeshiva University  Bronx New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire H.","family":"Sandoe","sequence":"additional","affiliation":[{"name":"Department of Neurology Women's College Hospital Centre for Headache  Toronto Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7966-7737","authenticated-orcid":false,"given":"Janet H.","family":"Ford","sequence":"additional","affiliation":[{"name":"Lilly Corporate Center Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Austin L.","family":"Hand","sequence":"additional","affiliation":[{"name":"Biostatistics IQVIA  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jakub P.","family":"Jedynak","sequence":"additional","affiliation":[{"name":"Lilly Corporate Center Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6559-1014","authenticated-orcid":false,"given":"Martha D.","family":"Port","sequence":"additional","affiliation":[{"name":"Lilly Corporate Center Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1316-6064","authenticated-orcid":false,"given":"Holland C.","family":"Detke","sequence":"additional","affiliation":[{"name":"Lilly Corporate Center Eli Lilly and Company  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,2,16]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419898868"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1526-4610.2007.01004.x"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-016-0599-8"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13829"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2016.02.013"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-018-0946-z"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.13613"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2007.05.008"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10072-014-1780-y"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10194-012-0482-1"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0025-6196(11)60561-2"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12464"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12468"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/NRL.0b013e3181a74c17"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417731348"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11916-012-0263-1"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182535d20"},{"key":"e_1_2_12_19_1","unstructured":"EMA.Prescribing informtaion: Emgality (Galcanezumab). 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