{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T02:21:09Z","timestamp":1788315669298,"version":"build-2803163510"},"reference-count":42,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T00:00:00Z","timestamp":1650931200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"IBSA Institut Biochimique S.A."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>A novel formulation of diclofenac, complexed with hydroxypropyl-\u03b2-cyclodextrin (HP\u03b2CD) as a solubility enhancer, in a prefilled syringe for self-administered subcutaneous injection may overcome the limitations of acute migraine treatments administered by oral, rectal, intramuscular, or intravenous routes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This multicentre, phase 2, double-blind, randomized, placebo-controlled, dose-finding pilot study evaluated the efficacy, safety and tolerability of three different doses (25\/50\/75\u2009mg\/1\u2009mL) of subcutaneous diclofenac sodium in the treatment of an acute migraine attack in 122 subjects. The primary efficacy endpoint was the percentage of patients pain-free at 2 hours after the study drug injection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A significantly higher percentage of patients in the 50\u2009mg diclofenac group 14 (46.7%) were pain-free at 2 hours when compared with placebo: 9 (29.0%) ( p\u2009=\u20090.01). The 50\u2009mg dose proved superior to placebo also in the majority of the secondary endpoints. The overall global impression favoured diclofenac vs placebo. There were no adverse events leading to study withdrawal. The majority of treatment-emergent adverse events were mild.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The 50\u2009mg dose of this novel formulation of diclofenac represents a valuable self-administered option for the acute treatment of migraine attacks. Trial registration: EudraCT Registration No. 2017-004828-29.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024221093712","type":"journal-article","created":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T03:18:22Z","timestamp":1650943102000},"page":"1058-1070","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":6,"title":["Self-administered subcutaneous diclofenac sodium in acute migraine attack: A randomized, double-blind, placebo-controlled dose-finding pilot study"],"prefix":"10.1177","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3797-8371","authenticated-orcid":false,"given":"Pierangelo","family":"Geppetti","sequence":"first","affiliation":[{"name":"Universit\u00e0 degli studi di Firenze, Dipartimento di Scienze della Salute, Florence, Italy"},{"name":"SOD Centro Cefalee e Farmacologia Clinica, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"De Cesaris","sequence":"additional","affiliation":[{"name":"SOD Centro Cefalee e Farmacologia Clinica, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6316-430X","authenticated-orcid":false,"given":"Silvia","family":"Benemei","sequence":"additional","affiliation":[{"name":"SOD Centro Cefalee e Farmacologia Clinica, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pietro","family":"Cortelli","sequence":"additional","affiliation":[{"name":"IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy"},{"name":"DIBINEM \u2013 Universit\u00e0 di Bologna Ospedale Bellaria, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina","family":"Cevoli","sequence":"additional","affiliation":[{"name":"DIBINEM \u2013 Universit\u00e0 di Bologna Ospedale Bellaria, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Pierangeli","sequence":"additional","affiliation":[{"name":"DIBINEM \u2013 Universit\u00e0 di Bologna Ospedale Bellaria, Bologna, Italy"},{"name":"Azienda per l\u2019Assistenza Sanitaria n. 5 Friuli Occidentale-Centro Cefalee, Presidio Ospedaliero di San Vito al Tagliamento, San Vito al Tagliamento, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5335-2438","authenticated-orcid":false,"given":"Valentina","family":"Favoni","sequence":"additional","affiliation":[{"name":"DIBINEM \u2013 Universit\u00e0 di Bologna Ospedale Bellaria, Bologna, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Lisotto","sequence":"additional","affiliation":[{"name":"Azienda per l\u2019Assistenza Sanitaria n. 5 Friuli Occidentale-Centro Cefalee, Presidio Ospedaliero di San Vito al Tagliamento, San Vito al Tagliamento, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanna","family":"Usai","sequence":"additional","affiliation":[{"name":"Fondazione I.R.C.C.S. 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