{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T19:19:38Z","timestamp":1791659978459,"version":"4.3.4"},"reference-count":20,"publisher":"SAGE Publications","issue":"11-12","license":[{"start":{"date-parts":[[2022,5,27]],"date-time":"2022-05-27T00:00:00Z","timestamp":1653609600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2022,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>CGAR, a Phase 3b open-label study, evaluated the long-term safety of galcanezumab in patients with cluster headache who completed one of two Phase 3 double-blind studies in chronic or episodic cluster headache.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients (N\u2009=\u2009164) received galcanezumab 300\u2009mg subcutaneously up to once a month. Primary endpoint was safety, as assessed by treatment-emergent adverse events, serious adverse events, and suicidality. Other endpoints included discontinuation rates, immunogenicity, efficacy as assessed by the Patient Global Impression of Improvement, and health values.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At baseline, mean (standard deviation) age was 48.3 (9.8) years, 75.0% were men, and 85.4% were white. Treatment-emergent adverse events (n\u2009=\u2009119 [72.6%]) were mostly mild-to-moderate, with nasopharyngitis the most commonly reported (22.0%). One of 18 serious adverse events was judged as treatment related (constipation). Two patients (1.2%) reported suicidal ideation. Five patients (3.1%) discontinued due to an adverse event. Eight patients were treatment-emergent anti-drug antibody positive, two of whom were not treatment-emergent anti-drug antibody positive in the parent studies. On the Patient Global Impression of Improvement, \u226581% reported their cluster headache status as very much, much, or a little better at Months 1, 6, and 12. Health value scores generally improved from baseline.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this open-label study, galcanezumab was generally well tolerated and improved patient-reported cluster headache status. Trial registration number: NCT02797951; https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02797951<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024221103509","type":"journal-article","created":{"date-parts":[[2022,5,28]],"date-time":"2022-05-28T01:13:50Z","timestamp":1653700430000},"page":"1225-1235","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":19,"title":["Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache"],"prefix":"10.1177","volume":"42","author":[{"given":"Robert","family":"Riesenberg","sequence":"first","affiliation":[{"name":"Atlanta Center for Medical Research, Atlanta, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charly","family":"Gaul","sequence":"additional","affiliation":[{"name":"Headache Center, Frankfurt, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chad E","family":"Stroud","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Dong","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark E","family":"Bangs","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Wenzel","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James M","family":"Martinez","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tina Myers","family":"Oakes","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company, Indianapolis, Indiana, United States"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,5,27]]},"reference":[{"key":"bibr1-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"bibr2-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2008.01592.x"},{"key":"bibr3-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413485658"},{"key":"bibr4-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420905321"},{"key":"bibr5-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813440"},{"key":"bibr6-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1111\/head.14234"},{"key":"bibr7-03331024221103509","unstructured":"United States Food and Drug Administration. FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks, https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-treatment-episodiccluster-headache-reduces-frequency-attacks, (2019, accessed September 28, 2021)."},{"key":"bibr8-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2011.10111704"},{"key":"bibr9-03331024221103509","author":"Guy W.","year":"1976","journal-title":"National Institute of Mental Health, Psychopharmacology Research Branch"},{"key":"bibr10-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1016\/0168-8510(90)90421-9"},{"key":"bibr11-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-011-9903-x"},{"key":"bibr12-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-020-1609-7"},{"key":"bibr13-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1111\/j.1742-7843.2004.pto940606.x"},{"key":"bibr14-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1038\/bjp.2008.334"},{"key":"bibr15-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1152\/physrev.00034.2013"},{"key":"bibr16-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1016\/j.npep.2010.12.002"},{"key":"bibr17-03331024221103509","first-page":"1161","volume":"18","author":"Lasaosa SS","year":"2017","journal-title":"Pain Med"},{"key":"bibr18-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0000000000000680"},{"key":"bibr19-03331024221103509","doi-asserted-by":"publisher","DOI":"10.2147\/JPR.S305066"},{"key":"bibr20-03331024221103509","doi-asserted-by":"publisher","DOI":"10.1111\/head.14011"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024221103509","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024221103509","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024221103509","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:49:35Z","timestamp":1777387775000},"score":1,"resource":{"primary":{"URL":"http:\/\/journals.sagepub.com\/doi\/10.1177\/03331024221103509"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,27]]},"references-count":20,"journal-issue":{"issue":"11-12","published-print":{"date-parts":[[2022,10]]}},"alternative-id":["10.1177\/03331024221103509"],"URL":"https:\/\/doi.org\/10.1177\/03331024221103509","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,27]]}}}