{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T12:52:43Z","timestamp":1769086363688,"version":"3.49.0"},"reference-count":21,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2020,11,11]],"date-time":"2020-11-11T00:00:00Z","timestamp":1605052800000},"content-version":"vor","delay-in-days":10,"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":[[2020,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency reduction and impact on acute treatment management, is lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a Phase 3, randomized, double\u2010blind, placebo\u2010controlled study in patients (men or women aged 18\u201065\u00a0years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders\u20103 beta criteria. In this post hoc analysis, we evaluated the median time\u2010to\u2010first occurrence of \u226550, \u226575, or 100% reduction from baseline in CH attack frequency, and impact on acute medication use. An anchor\u2010based assessment of clinically relevant attack frequency reduction using the Patient Global Impression of Improvement (PGI\u2010I) scores at Week 4 was also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The median time\u2010to\u2010first occurrence of \u226550, \u226575, or 100% reduction from baseline in CH attacks was consistently shorter (9\u201010\u00a0days sooner) with galcanezumab vs placebo (median [95% confidence interval, 95% CI]: \u226550%, 5\u00a0days [4.0 to 7.0] vs 14\u00a0days [6.0 to 19.0]; \u226575%, 11\u00a0days [7.0 to 16.0] vs 21\u00a0days [13.0 to 26.0]; 100%, 22\u00a0days [16.0 to 37.0] vs 32\u00a0days [23.0 to 34.0]). Mean reduction from baseline in the overall frequency of weekly pooled acute medication use across Weeks 1\u20103 was significantly greater with galcanezumab vs placebo (11.0 vs 5.5; odds ratio, OR [95% CI]: 5.52 [1.02, 10.01];\n                      <jats:italic>P<\/jats:italic>\n                      value\u00a0=\u00a0.017). Patients reporting \u201cmuch better\u201d on the PGI\u2010I experienced a median weekly CH attack reduction of approximately 43% from baseline across Weeks 1\u20103. The overall odds of achieving an attack reduction threshold of 43% across Weeks 1\u20103 was significantly higher with galcanezumab vs placebo (Weeks 1\u20103: OR [95% CI], 2.60 [1.3 to 5.3]).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Faster median time\u2010to\u2010first occurrence of response rates, lower frequency of pooled acute medications use, and a greater proportion of patients achieving a response anchored by patient\u2010reported improvement were observed for galcanezumab vs placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14011","type":"journal-article","created":{"date-parts":[[2020,11,12]],"date-time":"2020-11-12T02:17:18Z","timestamp":1605147438000},"page":"2254-2264","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache"],"prefix":"10.1111","volume":"60","author":[{"given":"David","family":"Kudrow","sequence":"first","affiliation":[{"name":"California Medical Clinic for Headache Santa Monica CA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J. Scott","family":"Andrews","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mallikarjuna","family":"Rettiganti","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tina","family":"Oakes","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer","family":"Bardos","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9362-3711","authenticated-orcid":false,"given":"Charly","family":"Gaul","sequence":"additional","affiliation":[{"name":"Migraine and Headache Clinic Koenigstein Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Riesenberg","sequence":"additional","affiliation":[{"name":"Atlanta Center for Medical Research Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Wenzel","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dulanji","family":"Kuruppu","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Martinez","sequence":"additional","affiliation":[{"name":"Eli Lilly and Company Indianapolis IN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,11,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2008.01592.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1468-2982.2002.00463.x"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102410391489"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2003.00655.x"},{"key":"e_1_2_10_7_1","first-page":"172","article-title":"Cluster headache: Investigating severity of pain, suicidality, personal burden, access to effective treatment, and demographics among a large international survey sample, abstract","volume":"37","author":"Schor LI","year":"2017","journal-title":"Cephalalgia"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417714477"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12866"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-1331.2006.01566.x"},{"key":"e_1_2_10_11_1","first-page":"213","article-title":"Treatment guidelines for acute and preventive treatment of cluster headache","volume":"20","author":"Treatment Guideline Subcommittee of the Taiwan Headache Society","year":"2011","journal-title":"Acta Neurol Taiwan"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10194-012-0437-6"},{"key":"e_1_2_10_13_1","doi-asserted-by":"crossref","first-page":"P5.10\u2010015","DOI":"10.1212\/WNL.92.15_supplement.P5.10-015","article-title":"Acute and preventive treatment patterns in episodic cluster headache: Findings from the United States, United Kingdom and Germany (P5.10\u2010015)","volume":"92","author":"Nichols R","year":"2019","journal-title":"Neurology"},{"key":"e_1_2_10_14_1","volume-title":"Prescribing Information: Emgality (Galcanezumab)","author":"FDA Labelling Packaging Insert","year":"2019"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813440"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102413485658"},{"key":"e_1_2_10_17_1","volume-title":"IMITREX (Sumatriptan Succinate) Injection, for Subcutaneous Use: US Prescribing Information","author":"Prescribing Information: IMITREX","year":"2015"},{"key":"e_1_2_10_18_1","first-page":"217","volume-title":"ECDEU Assessment Manual for Psychopharmacology, Revised 1976","author":"Guy W"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102411425866"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.54.6.1382"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0025-6196(11)60561-2"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2008.01555.x"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14011","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/head.14011","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14011","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T12:35:46Z","timestamp":1762086946000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14011"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11]]},"references-count":21,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1111\/head.14011"],"URL":"https:\/\/doi.org\/10.1111\/head.14011","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,11]]},"assertion":[{"value":"2020-06-23","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-10-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-11-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}