{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T01:16:10Z","timestamp":1792026970112,"version":"4.4.0"},"reference-count":48,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T00:00:00Z","timestamp":1743465600000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,4,1]],"date-time":"2025-04-01T00:00:00Z","timestamp":1743465600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/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":[[2025,4]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Focusing on calcitonin gene-related peptide (CGRP) as a specific target has changed and improved migraine management. After the positive results of monoclonal antibodies directed to the CGRP pathway (anti-CGRP mAbs), randomized controlled trials also demonstrated the efficacy of gepants in migraine prevention. The present study aimed to assess the effectiveness of atogepant in preventing migraine after a 12-week treatment in clinical practice.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adult patients with a clinical indication for atogepant 60 mg daily were screened for participation in this multicentric prospective observational cohort study. At baseline (T0) and after 12 weeks (T3) since the first atogepant administration, monthly migraine days (MMDs), monthly headache days (MHDs) and monthly acute medications (MAMs) were assessed. The co-primary endpoints were the changes in MMDs from T0 to T3 and the percentage of T3 Responders (those with a reduction of MMDs \u226550%, i.e. 50% response rate (RR)). At T0 and T3, we also collected the Headache Impact Test (HIT-6), the Migraine Disability Assessment (MIDAS) questionnaire, the Migraine Treatment Optimization Questionnaire-6 (mTOQ-6), the Migraine-Specific Quality-of-Life Questionnaire (MSQ), the 12-item Allodynia Symptom Checklist (ASC-12) and the Migraine Interictal Burden Scale (MIBS-4).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      One hundred and six patients (56\/106 (52.8%) with chronic migraine (CM), 93\/106 (87.7%) female, aged 50.6\u2009\u00b1\u200913.2 years) from 10 Italian centers completed the 12-week observation since the first atogepant tablet intake. From baseline to T3, a reduction of 6.9 MMDs (SD 9.7;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.001) was achieved in the whole group and, specifically, of \u22124.9 (SD 6.6;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.001) in episodic migraine (EM) and of \u22128.6 (SD 11.7;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.001) in CM patients. Overall, 60\/106 (56.6%) of patients were Responders (60.0% in the EM and 46.4% in the CM group). Non-Responders previously experienced more ineffective treatments than Responders with anti-CGRP mAbs (65.2% vs. 43.3%, respectively,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.031) and with onabotulinumtoxinA (56.5% vs. 28.3%,\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.005), and presented more medication overuse at baseline (55.7% vs. 44.3%, p\u2009=\u20090.003). However, no baseline characteristics were significantly associated with the Responder status in the multiple regression analysis. For T0 to T3, MAMs, MIDAS, ASC-12 and mTOQ-6 reduced (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009\u2264\u20090.001 consistently), and MSQ role-function restriction increased (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.026), whereas HIT-6 and MIBS-4 did not change. Only seven subjects (7\/106, 6.6%) dropped out of atogepant treatment: four for lack of effectiveness and three for adverse events or poor tolerability.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The STAR study demonstrates the effectiveness and tolerability of atogepant 60 mg at 12 weeks in a real-world setting. Previous ineffective anti-CGRP mAbs were not a relevant prognostic factor.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>The study was preregistered on clinicaltrial.gov, NCT06414044.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024251335927","type":"journal-article","created":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T14:46:07Z","timestamp":1745419567000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":25,"title":["Effectiveness and tolerability of atogepant in the prevention of migraine: A real life, prospective, multicentric study (the STAR study)"],"prefix":"10.1177","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9594-9336","authenticated-orcid":false,"given":"Fabrizio","family":"Vernieri","sequence":"first","affiliation":[{"name":"Fondazione Policlinico Universitario Campus Bio-Medico"},{"name":"Neurology Unit, Universit\u00e0 Campus Bio-Medico di Roma"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3598-0195","authenticated-orcid":false,"given":"Luigi Francesco","family":"Iannone","sequence":"additional","affiliation":[{"name":"Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, Modena, Italy"},{"name":"University of Modena and Reggio Emilia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavia","family":"Lo Castro","sequence":"additional","affiliation":[{"name":"Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, Modena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4231-4417","authenticated-orcid":false,"given":"Gabriele","family":"Sebastianelli","sequence":"additional","affiliation":[{"name":"Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, Latina, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8059-6427","authenticated-orcid":false,"given":"Federico","family":"De Santis","sequence":"additional","affiliation":[{"name":"Department of Biotechnological and Applied Clinical Sciences"},{"name":"University of L'Aquila"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Corrado","sequence":"additional","affiliation":[{"name":"University of Pavia"},{"name":"IRCCS Mondino Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marilena","family":"Marcosano","sequence":"additional","affiliation":[{"name":"Fondazione Policlinico Universitario Campus Bio-Medico"},{"name":"Neurology Unit, Universit\u00e0 Campus Bio-Medico di Roma"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9501-4031","authenticated-orcid":false,"given":"Raffaele","family":"Ornello","sequence":"additional","affiliation":[{"name":"Department of Biotechnological and Applied Clinical Sciences"},{"name":"University of L'Aquila"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6535-1109","authenticated-orcid":false,"given":"Licia","family":"Grazzi","sequence":"additional","affiliation":[{"name":"Fondazione IRCCS Istituto Neurologico Carlo Besta"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4834-2045","authenticated-orcid":false,"given":"Danilo Antonio","family":"Montisano","sequence":"additional","affiliation":[{"name":"Fondazione IRCCS Istituto Neurologico Carlo Besta"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"De Cesaris","sequence":"additional","affiliation":[{"name":"Headache center and Clinical Pharmacology, AOU Careggi, Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Munaf\u00f2","sequence":"additional","affiliation":[{"name":"Headache center and Clinical Pharmacology, AOU Careggi, Florence, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7958-5440","authenticated-orcid":false,"given":"Luisa","family":"Fofi","sequence":"additional","affiliation":[{"name":"Fondazione Policlinico Universitario Campus Bio-Medico"},{"name":"Headache Unit, Ospedale S. Pietro Fatebenefratelli, Roma, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto","family":"Doretti","sequence":"additional","affiliation":[{"name":"IRCCS Istituto Auxologico Italiano"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0117-7126","authenticated-orcid":false,"given":"Gloria","family":"Vaghi","sequence":"additional","affiliation":[{"name":"University of Pavia"},{"name":"IRCCS Mondino Foundation"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Pistoia","sequence":"additional","affiliation":[{"name":"Department of Biotechnological and Applied Clinical Sciences"},{"name":"University of L'Aquila"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delfina","family":"Ferrandi","sequence":"additional","affiliation":[{"name":"Neurology Department, Azienda Ospedaliero Universitaria, Santi Antonio e Biagio e Cesare Arrigo, Alessandria, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefania","family":"Battistini","sequence":"additional","affiliation":[{"name":"Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0651-1939","authenticated-orcid":false,"given":"Simona","family":"Sacco","sequence":"additional","affiliation":[{"name":"Department of Biotechnological and Applied Clinical Sciences"},{"name":"University of L'Aquila"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Guerzoni","sequence":"additional","affiliation":[{"name":"Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, Modena, Italy"},{"name":"University of Modena and Reggio Emilia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5934-5535","authenticated-orcid":false,"given":"Claudia","family":"Altamura","sequence":"additional","affiliation":[{"name":"Fondazione Policlinico Universitario Campus Bio-Medico"},{"name":"Neurology Unit, Universit\u00e0 Campus Bio-Medico di Roma"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"on behalf of the Italian Headache Registry (RICe) Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,4,23]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1038\/s41582-018-0003-1"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.14692"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-022-01431-x"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10072-022-06184-8"},{"key":"e_1_3_3_6_2","doi-asserted-by":"crossref","unstructured":"Olesen J Diener H-C Husstedt IW et al. Calcitonin Gene-Related Peptide Receptor Antagonist BIBN 4096 BS for the Acute Treatment of Migraine www.nejm.org (2004).","DOI":"10.1056\/NEJMoa030505"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3181b87942"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1813049"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31606-X"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(22)00517-8"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32544-7"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40120-023-00562-w"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(20)30234-9"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2035908"},{"key":"e_1_3_3_15_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.14439"},{"key":"e_1_3_3_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(23)01049-8"},{"key":"e_1_3_3_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(24)00025-5"},{"key":"e_1_3_3_18_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-023-01050-3"},{"key":"e_1_3_3_19_2","doi-asserted-by":"publisher","DOI":"10.1111\/ene.16450"},{"key":"e_1_3_3_20_2","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_3_3_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2004.05.004"},{"key":"e_1_3_3_22_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.0333-1024.2001.00277.x"},{"key":"e_1_3_3_23_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-2982.2008.01786.x"},{"key":"e_1_3_3_24_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-013-0556-9"},{"key":"e_1_3_3_25_2","doi-asserted-by":"publisher","DOI":"10.1002\/ana.21211"},{"key":"e_1_3_3_26_2","first-page":"741","volume-title":"Headache","author":"Buse D","year":"2007","unstructured":"Buse D, Bigal M, Ruponow M, et al. The migraine interictal burden scale (MIBS): Results of a population-based validation study-49th Annual Scientific Meeting American Headache Society. In: Headache. Chicago, IL: John Wiley & Sons, Ltd, 2007, pp.741\u2013812."},{"key":"e_1_3_3_27_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jmpt.2003.11.003"},{"key":"e_1_3_3_28_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.12553"},{"key":"e_1_3_3_29_2","doi-asserted-by":"publisher","DOI":"10.1177\/0333102416678382"},{"key":"e_1_3_3_30_2","first-page":"333102424129975","article-title":"Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis","volume":"44","author":"Peterlin BL","unstructured":"Peterlin BL, Bond DS, Ailani J, et al. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia Epub ahead of print 1 December 2024; 44: 3331024241299753.","journal-title":"Cephalalgia"},{"key":"e_1_3_3_31_2","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2083"},{"key":"e_1_3_3_32_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp2200089"},{"key":"e_1_3_3_33_2","doi-asserted-by":"publisher","DOI":"10.1111\/ene.15563"},{"key":"e_1_3_3_34_2","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-022-01498-6"},{"key":"e_1_3_3_35_2","doi-asserted-by":"publisher","DOI":"10.1111\/ene.15197"},{"key":"e_1_3_3_36_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.14903"},{"key":"e_1_3_3_37_2","doi-asserted-by":"publisher","DOI":"10.1111\/head.14865"},{"key":"e_1_3_3_38_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2022.174902"},{"key":"e_1_3_3_39_2","doi-asserted-by":"publisher","DOI":"10.1177\/03331024231159366"},{"key":"e_1_3_3_40_2","doi-asserted-by":"publisher","DOI":"10.1016\/B978-0-12-823357-3.00024-0"},{"key":"e_1_3_3_41_2","doi-asserted-by":"publisher","DOI":"10.1177\/03331024231226186"},{"key":"e_1_3_3_42_2","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1111\/head.14716","article-title":"Antagonism by ubrogepant and atogepant of agonist-mediated human CGRP receptor \u03b2 -arrestin recruitment and internalization in transfected cells- American Headache Society 66th Annual Scientific Meeting June 13\u201316, 2024 San Diego, California","volume":"64","author":"Hay D","year":"2024","unstructured":"Hay D, Alexander T, Nimick M, et al. Antagonism by ubrogepant and atogepant of agonist-mediated human CGRP receptor \u03b2 -arrestin recruitment and internalization in transfected cells- American Headache Society 66th Annual Scientific Meeting June 13\u201316, 2024 San Diego, California. Headache J Head Face Pain 2024; 64: 3\u2013232.","journal-title":"Headache J Head Face Pain"},{"key":"e_1_3_3_43_2","doi-asserted-by":"publisher","DOI":"10.3390\/ph16070934"},{"key":"e_1_3_3_44_2","doi-asserted-by":"publisher","DOI":"10.1212\/01.wnl.0000262045.11646.b1"},{"key":"e_1_3_3_45_2","doi-asserted-by":"publisher","DOI":"10.1358\/dnp.2010.23.2.1475909"},{"key":"e_1_3_3_46_2","first-page":"3","article-title":"Pharmacological characterization of ubrogepant andatogepant antagonism in adipocyte cell models","author":"Hay D","year":"2024","unstructured":"Hay D, Walker C, Wang D, et al. Pharmacological characterization of ubrogepant andatogepant antagonism in adipocyte cell models. In: Headache. American Headache Society 66th Annual Scientific Meeting June 13\u201316, 2024 San Diego, California: Wiley, 2024, pp. 3\u2013232.","journal-title":"Headache"},{"key":"e_1_3_3_47_2","doi-asserted-by":"publisher","DOI":"10.3390\/nu17020337"},{"key":"e_1_3_3_48_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.metop.2020.100060"},{"key":"e_1_3_3_49_2","doi-asserted-by":"publisher","DOI":"10.1210\/en.2004-1424"}],"container-title":["Cephalalgia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024251335927","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/03331024251335927","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/03331024251335927","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T14:46:51Z","timestamp":1777387611000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/03331024251335927"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4]]},"references-count":48,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2025,4]]}},"alternative-id":["10.1177\/03331024251335927"],"URL":"https:\/\/doi.org\/10.1177\/03331024251335927","relation":{},"ISSN":["0333-1024","1468-2982"],"issn-type":[{"value":"0333-1024","type":"print"},{"value":"1468-2982","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4]]},"article-number":"03331024251335927"}}