{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,5]],"date-time":"2026-11-05T15:20:53Z","timestamp":1793892053589,"version":"4.8.0"},"reference-count":33,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T00:00:00Z","timestamp":1748563200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013327","name":"H. Lundbeck A\/S","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013327","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>The primary objective was to characterize the pharmacokinetics (PK) and safety of eptinezumab in children and adolescents with migraine.<\/jats:p><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>Migraine in children and adolescents is a prevalent and potentially debilitating disease, and few preventive therapies are approved for use in these populations. Eptinezumab, a calcitonin gene\u2010related peptide monoclonal antibody approved for migraine prevention in adults, has demonstrated efficacy at doses of 100\u2009mg or 300\u2009mg administered intravenously every 12\u2009weeks. Defining the appropriate dosing of eptinezumab in children and adolescents is required to accurately examine the safety and efficacy of its use as a preventive migraine therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this open\u2010label PK clinical trial conducted between August 2020 and October 2022, children and adolescents with migraine (aged 6\u201317\u2009years) received weight\u2010adjusted intravenous eptinezumab infusions. The doses were designed to match the exposure from a 300\u2009mg dose in adults. The trial included a 28\u2010day screening period, a 20\u2010week main trial period, and an optional 44\u2010week multiple\u2010dose extension period. Participants were dosed on Day 1 and had follow\u2010up visits at Weeks 4, 8, 12, and 20. The extension period included three additional eptinezumab infusions every 12\u2009weeks. Primary PK endpoints included area under the curve (from zero to infinity; AUC<jats:sub>0\u2013inf<\/jats:sub>) of eptinezumab and maximum concentration (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>). The effect of eptinezumab on migraine\u2010related disability was explored using the Pediatric Migraine Disability Assessment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 28 participants (12 children [aged 6\u201311\u2009years] and 16 adolescents [aged 12\u201317\u2009years]) were enrolled in the trial, with 23 continuing into the extension period. A single intravenous administration of eptinezumab at 150\u2009mg or 300\u2009mg resulted in similar mean plasma concentration\u2013time curves (mean AUC<jats:sub>0\u2013inf<\/jats:sub>: 92,890\u2009h\u00b7\u03bcg\/mL [150\u2009mg], 95,550\u2009h\u00b7\u03bcg\/mL [300\u2009mg]; mean <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>: 131.8\u2009\u03bcg\/mL [150\u2009mg], 141.2\u2009\u03bcg\/mL [300\u2009mg]). The PK profile of eptinezumab after multiple intravenous administrations in the extension period was also similar. No serious adverse events (AEs) or severe treatment\u2010emergent AEs (TEAEs) were observed. The most common TEAE was orthostatic hypotension, reported in three adolescents (11% of total population). Other TEAEs occurred as single incidences. Improvement in migraine\u2010associated disability was seen in both children and adolescents after a single intravenous administration of eptinezumab (median [range] score changes from baseline to Week 12 were \u221222 [\u221270, \u22126] in children and \u221217.0 [\u2212117, 42] in adolescents) and was maintained during the extension period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The PK profile in children and adolescents was consistent across different dose levels and weight groups. These results support the use of weight\u2010based eptinezumab dosing in children and adolescents with migraine. Eptinezumab was generally well tolerated, with no new safety signals observed in this population relative to those observed in adults.<\/jats:p><\/jats:sec>","DOI":"10.1111\/head.14959","type":"journal-article","created":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T06:45:09Z","timestamp":1748587509000},"page":"1573-1583","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine"],"prefix":"10.1111","volume":"65","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1598-7536","authenticated-orcid":false,"given":"Andrew D.","family":"Hershey","sequence":"first","affiliation":[{"name":"Department of Neurology Cincinnati Children's Hospital Medical Center  Cincinnati Ohio USA"},{"name":"Department of Pediatrics University of Cincinnati College of Medicine  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9767-9643","authenticated-orcid":false,"given":"Johan","family":"Areberg","sequence":"additional","affiliation":[{"name":"H. Lundbeck A\/S  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3062-8881","authenticated-orcid":false,"given":"Line Pickering","family":"Boserup","sequence":"additional","affiliation":[{"name":"H. Lundbeck A\/S  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annika","family":"Lindsten","sequence":"additional","affiliation":[{"name":"H. Lundbeck A\/S  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Rosen","sequence":"additional","affiliation":[{"name":"H. Lundbeck A\/S  Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,30]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-8749.2010.03793.x"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11916-013-0341-z"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-023-01541-0"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102409355601"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e318271f812"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.3399\/bjgp09X454142"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11910-010-0175-6"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000008105"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-077916"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11916-023-01157-8"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32160-7"},{"key":"e_1_2_12_13_1","volume-title":"Vyepti (eptinezumab\u2010jjmr)","year":"2022"},{"key":"e_1_2_12_14_1","unstructured":"Vyepti (eptinezumab). Updated November 29 2022. Accessed September 27 2023.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/vyepti."},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(22)00185-5"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-021-01227-5"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2020.11.007"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102420905132"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000009169"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-021-02123-w"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-020-01186-3"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2024.1355877"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-023-01688-w"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.567"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcpt.14076"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_12_27_1","unstructured":"U.S. Centers for Disease Control and Prevention National Center for Health Statistics.CDC Growth Charts. Accessed August 14 2024.https:\/\/www.cdc.gov\/growthcharts\/cdc\u2010growth\u2010charts.htm"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.57.11.2034"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419842188"},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.1177\/03331024231178239"},{"key":"e_1_2_12_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0304-3959(00)00305-5"},{"key":"e_1_2_12_32_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.56.suppl_1.s20"},{"key":"e_1_2_12_33_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12883-022-02774-3"},{"key":"e_1_2_12_34_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.14452"}],"container-title":["Headache: The Journal of Head and Face Pain"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/head.14959","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T19:34:26Z","timestamp":1760556866000},"score":1,"resource":{"primary":{"URL":"https:\/\/headachejournal.onlinelibrary.wiley.com\/doi\/10.1111\/head.14959"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5,30]]},"references-count":33,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1111\/head.14959"],"URL":"https:\/\/doi.org\/10.1111\/head.14959","archive":["Portico"],"relation":{},"ISSN":["0017-8748","1526-4610"],"issn-type":[{"value":"0017-8748","type":"print"},{"value":"1526-4610","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5,30]]},"assertion":[{"value":"2024-10-31","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-03-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-05-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}