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Here, we present 24-week eptinezumab efficacy and safety in the RESOLUTION trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>RESOLUTION was a randomized, parallel-group, multinational clinical trial that included a 12-week double-blind, placebo-controlled period and a 12-week open-label extension period (OLE). Adults (18\u201375\u2009years) with CM and MOH (excluding opioid-overuse headache) received a brief educational intervention about MOH at baseline and were randomized (1:1) to IV eptinezumab 100\u2009mg or placebo. At Week 12, all participants received eptinezumab 100\u2009mg. Measures used for primary and key secondary efficacy endpoints were also captured during the OLE: mean changes from baseline in monthly migraine days (primary endpoint: Weeks 1\u20134), monthly headache days, monthly days with acute medication use, average daily pain, and participants no longer meeting threshold criteria for CM nor MOH. Secondary endpoints (including patient-reported-outcomes [PROs] assessing disease-related burden and health-related QOL) and treatment-emergent adverse events (TEAEs) were also captured during the OLE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 608 participants randomized, 593 (97.5%) were treated with eptinezumab in the OLE, and 584\/608 (96.1%) completed the trial. Reductions in migraine frequency and active CM\/MOH diagnosis, and improvements across multiple PROs observed in\n                      <jats:italic>post hoc<\/jats:italic>\n                      analyses during the placebo-controlled period were sustained during the OLE for participants initially treated with eptinezumab, with similar levels of improvement gained for those initially receiving placebo. The proportion of participants with TEAEs in the OLE was similar between eptinezumab\u2013eptinezumab and placebo\u2013eptinezumab treatment sequence groups (30% vs 34%); no new safety signals were identified.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In participants with CM and MOH who received patient education, reductions in disease burden and improvements in QOL during the first 12\u2009weeks with eptinezumab treatment were sustained for up to 24\u2009weeks following a second eptinezumab infusion, with similar improvements observed in participants switched from placebo to eptinezumab. Eptinezumab was generally well tolerated, with no new safety signals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov Identifier: NCT05452239 (https:\/\/clinicaltrials.gov\/study\/NCT05452239); EudraCT Number: 2021-003049-40 (https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=2021-003049-40)<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s10194-026-02423-x","type":"journal-article","created":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T06:04:15Z","timestamp":1781330655000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of eptinezumab in adults with chronic migraine and medication-overuse headache who also received patient education: 24-week results of the randomized RESOLUTION trial"],"prefix":"10.1186","volume":"27","author":[{"given":"Henrik W.","family":"Schytz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rigmor H.","family":"Jensen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christofer","family":"Lundqvist","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Tassorelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrizio","family":"Vernieri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Lant\u00e9ri-Minet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gisela M.","family":"Terwindt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Blumenfeld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stewart J.","family":"Tepper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mette Krog","family":"Josiassen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary","family":"Jansson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Ettrup","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aur\u00e9lia","family":"Mittoux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B.","family":"Lipton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,13]]},"reference":[{"issue":"4","key":"2423_CR1","doi-asserted-by":"publisher","first-page":"631","DOI":"10.1016\/j.ncl.2019.06.001","volume":"37","author":"RC Burch","year":"2019","unstructured":"Burch RC, Buse DC, Lipton RB (2019) Migraine: epidemiology, burden, and Comorbidity. 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The appropriate ethics committee or institutional review board for each site approved the trial; all participants provided written informed consent before trial participation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"RHJ has given lectures for Allergan, ATI, Eli Lilly, Lundbeck, Merck, Novartis, Pfizer, and Teva; served as investigator in clinical trials with ATI, Eli Lilly, Lundbeck, Novartis, and Novo Nordisk; is the director of the Danish Headache Center, Lifting The Global Burden of Headache, and Founder of Master of Headache Disorders at University of Copenhagen; and has received research funding from ATI, Lundbeck Foundation, The Medical Society in Copenhagen, Novo Nordisk Foundation, Rigshospitalet, Tryg Foundation, and University of Copenhagen. CL has participated on an advisory board and received payment for lectures arranged by AbbVie, Lundbeck, Novartis AS, and Roche AS, and has received research sponsorship from AbbVie Pharma. HWS has received personal fees from AbbVie, Eli Lilly, Lundbeck, Novartis, and Teva, and has received research grants from Novartis and Novo Nordisk Foundation. CT in the past 3\u2009years has received support (financial or drugs) from AbbVie and Novartis for an investigator-initiated trial; consulting fees for the participation in advisory boards for AbbVie, Eli Lilly, Ipsen, Lundbeck, Pfizer, Organon and Teva; honoraria for scientific lectures and presentations from AbbVie, Eli Lilly, Lundbeck, Pfizer, Organon and Teva; support for attending meetings from AbbVie, Eli Lilly, Ipsen, Lundbeck, Pfizer, and Teva; has been Principal Investigator in clinical trials sponsored by AbbVie, Biohaven, Chordate, Eli Lilly, Ipsen, Lundbeck, Pfizer, and Teva; and received grants from the European Commission, the Italian Ministry of Health, and the Italian Ministry of University. FV has received financial support from AbbVie, Angelini, and Lundbeck for investigator-initiated trials; consulting fees for the participation in advisory boards from AbbVie, Angelini, Eli Lilly, Lundbeck, Organon, Novartis, Pfizer, and Teva; honoraria for scientific lectures and presentations from AbbVie, Eli Lilly, Lundbeck, Novartis, Organon, Pfizer, and Teva; support for attending meetings from AbbVie, Eli Lilly, Lundbeck, Pfizer, and Teva; and has been Principal Investigator in clinical trials sponsored by AbbVie, Eli Lilly, Lundbeck, Pfizer, and Teva. ML-M reports personal fees for advisory boards, speaker panels, or investigation studies from Allergan, Amgen, Astellas, ATI, BMS, Boehringer, Boston Scientific, CoLucid, Convergence, Eli Lilly, GlaxoSmithKline, Grunenthal, Eli Lilly, Ipsen, Lundbeck, Medtronic, MSD, Novartis, Orion Pharma, Perfood, Pfizer, Reckitt Benckiser, St. Jude, Salvia BioElectronics, Sanofi-Aventis, Teva, UCB, UPSA, and Zambon. He is associate editor to JHP. GMT reports grants or consultancy support from AbbVie, Eli Lilly, Lundbeck, Novartis, Organon, Pfizer, Salvia, Teva, and Interactive Studios and independent support from the Clayco Foundation, Dioraphte Foundation, Dutch Brain Foundation, Dutch Heart Foundation, Dutch Research Council, IRRF, and the European Community. AB has served on advisory boards for AbbVie, Aeon, Alder, Amgen, Biohaven, Eaglet, Eli Lilly, Impel, Lundbeck, Novartis, Promius, Revance, Supernus, and Teva; and has received funding for speaking from AbbVie, Amgen, Avanir, Biohaven, Depomed, Eli Lilly, Impel, Lundbeck, Pernix, Promius, Supernus, and Teva. SJT reports grants for research from Abbvie, Aeon, Amgen, Annovis, Axsome, Bristol Myer Squibb, Cassava, Cognition, Eli Lilly, Genentec, Inhibikase, Ipsen, Johnson and Johnson\/Intracellular, Karuna, Lundbeck, Merz, Neurocrine, Novartis, Pfizer, PrecisionMed, Revance, Sanofi, Suven, UCB, and Upsher Smith, has served a consultant and\/or Advisory Boards with honoraria for Abbvie, Aeon, Alphasights, Amgen, Amneal, Aruene\/eNeura, Atheneum, Axsome Therapeutics, Bausch Health, Becker Pharmaceutical Consulting, Catch Therapeutics, ClearView Healthcare Partners, ClickTherapeutics, CoolTech, CRG, Decision Resources, Defined Health, DRG, DocDelta, Dr. Reddy\u2019s, Eli Lilly, ExpertConnect, FCB Health, Fenix, Gilmartin Capital, GLG, Guidepoint Global, Health Advances, Health Science Communications, HMP Communications, Impel, InteractiveForums, IQVIA, Keyquest, KLJ Associates, Krog and Partners, Lundbeck, M3 Global Research, Magellan Health, Magnolia Innovation, MJH Holdings, Neurofront Therapeutics, Nocira,\n                      p\n                      Value Communications, Pain Insights, Inc, Palion Medical, Paragon Therapeutics, Perfood, Pfizer, Putnam Associates, Rehaler, SAI MedPartners, Satsuma, Scilex, Slingshot Insights, Spherix Global Insights, Sprigings Intellectual Property Law, Strategy Inc, Synapse Medical Communication, System Analytic, Taylor and Francis, Tegus, Theranica, Third Bridge, Tonix, Trinity Partners, and Vial, received salary from Thomas Jefferson University and Ki Health Partners, served on the speakers bureau for AbbVie, Amneal, Axsome, Dr. Reddy\u2019s, Eli Lilly, Lundbeck, Pfizer, Scilex, Teva, and Tonix, received CME honoraria from the American Headache Society, Consortium for Research Education Social Awareness and Training In Neurosciences, Diamond Education Foundation, Forefront Collaborative, HMP Global, Medical Education Speakers Network, Medical Learning Institute Peerview, Miller Medical Education, National Association for Continuing Education, North American Center for CME, Physicians\u2019 Education Resource, PlatformQ Education, Primed, Vindico Medical Education, and WebMD\/Medscape, received travel support from AbbVie, American Headache Society, Amneal, Axsome, Diamond Headache Clinic, Dr. Reddy\u2019s, Eli Lilly, Lundbeck, and Pfizer, and received book royalties from Springer Health. MKJ, GJ, AE, and AM are full-time employees of H. Lundbeck A\/S. RBL has received research support from the National Institutes of Health, the FDA, and the National Headache Foundation. He serves as consultant, advisory board member, or has received honoraria or research support from AbbVie\/Allergan, Amgen, Axon, Axsome, Biohaven, Eli Lilly, GlaxoSmithKline, Lilly, Lundbeck, Merck, Novartis, Pfizer, Teva, Vector, and Vedanta Research; receives royalties from Wolff\u2019s Headache, 8th edition (Oxford University Press, 2009) and Informa; and holds stock\/options in Biohaven, Cooltech, and NuVieBio.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"157"}}