{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T16:43:44Z","timestamp":1787330624967,"version":"build-2736575974"},"reference-count":32,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"DOI":"10.13039\/100006259","name":"Teva Pharmaceuticals","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100006259","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Fremanezumab is approved for migraine prevention in Europe, the United States (US), Japan, South Korea, and several other countries; however, there are no data available on fremanezumab as a migraine preventive treatment in a Chinese population. This study evaluated the efficacy and safety of fremanezumab in Chinese adults with migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This randomized, multicenter, Phase 3 trial consisted of a 4-week screening period, a 12-week double-blind period (DBP), and a 12-week open-label extension (OLE). Chinese adults with episodic and chronic migraine were randomized 1:1:2 to receive fremanezumab monthly (225\u2005mg), fremanezumab quarterly (675\u2005mg), or matched monthly placebo during the DBP. During the OLE, all participants received fremanezumab monthly (225\u2005mg). The primary endpoint was mean change from baseline in monthly migraine days (MMD) during the DBP. Secondary endpoints included mean change from baseline in migraine days during the first 4 weeks of treatment and in monthly number of days with acute headache medication use during the DBP. Similar endpoints were assessed during the OLE. Safety assessments included, but were not limited to, adverse event (AE) reporting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 365\/454 screened participants were randomized to fremanezumab (n\u2009=\u2009182 [monthly, n\u2009=\u200991; quarterly, n\u2009=\u200991]) or placebo (n\u2009=\u2009183). Significantly greater changes from baseline in MMD were observed with fremanezumab versus placebo during the DBP (\u22124.6 vs \u22122.8;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.0001) and in mean migraine days during the first 4 weeks of treatment (\u22124.5 vs \u22122.2;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.0001). The mean change from baseline in days of acute headache medication use during the DBP was \u22123.0 with fremanezumab and \u22121.1 for placebo (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.0001). During the OLE, the mean change from baseline in MMD was \u22126.8 and \u22127.2 for those assigned to fremanezumab and placebo, respectively, during the DBP. The percentage of participants with any AE was similar between fremanezumab and placebo groups during the DBP (47% vs 43%); serious AEs were infrequent (fremanezumab, 1%; placebo, &lt;1%). Similar trends in AEs were observed during the OLE.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this study, fremanezumab demonstrated significant improvements over placebo with respect to reductions in MMD and days with acute headache medication use, with these reductions being maintained over the OLE. Fremanezumab demonstrated a favorable safety profile, with no safety signals. These results are comparable to pivotal adult trials in Europe and the US, supporting the use of fremanezumab in Chinese adults living with migraine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial pre-registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov identifier: NCT05458011; submitted: 11 July 2022; first participant enrolled: 30 September 2022; available at:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT05458011\">https:\/\/clinicaltrials.gov\/study\/NCT05458011<\/jats:ext-link>\n                      ; first submitted: 11 July 2022).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024261462833","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T15:03:29Z","timestamp":1787151809000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Fremanezumab for the preventive treatment of migraine in Chinese adults: A Phase 3, randomized controlled trial with an open-label extension"],"prefix":"10.1177","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8933-088X","authenticated-orcid":false,"given":"Shengyuan","family":"Yu","sequence":"first","affiliation":[{"name":"Department of Neurology, Chinese PLA General Hospital, First Medical Center, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Su","sequence":"additional","affiliation":[{"name":"Department of Neurology, Chinese PLA General Hospital, First Medical Center, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hebo","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hebei General Hospital, Shijiazhuang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meiyun","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tianjin Union Medical Center, Tianjin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steve","family":"Barash","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Glenn","family":"Chen","sequence":"additional","affiliation":[{"name":"Teva Pharmaceutical Information Consulting (Shanghai) Co., Ltd, Beijing, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gloria","family":"Yiu","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juline","family":"Bryson","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoel","family":"Kessler","sequence":"additional","affiliation":[{"name":"Teva Pharmaceutical Industries Ltd"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yael","family":"Carmeli Schwartz","sequence":"additional","affiliation":[{"name":"Teva Pharmaceutical Industries Ltd"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zipi","family":"Roth-Ben Arie","sequence":"additional","affiliation":[{"name":"Teva Pharmaceutical Industries Ltd"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michal","family":"Benedek-Segal","sequence":"additional","affiliation":[{"name":"Teva Pharmaceutical Industries Ltd"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-2900-6900","authenticated-orcid":false,"given":"Xiaoping","family":"Ning","sequence":"additional","affiliation":[{"name":"Teva Branded Pharmaceutical Products R&amp;D, Inc., West Chester, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.3389\/fneur.2021.800605"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)32162-0"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12955-016-0542-3"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2024.2349791"},{"key":"e_1_3_3_6_2","unstructured":"Teva UK Limited. AJOVY Summary of Product Characteristics. Available from: https:\/\/www.medicines.org.uk\/emc\/product\/10386\/smpc\/print (2024 accessed November 2025)."},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2018.4853"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1709038"},{"key":"e_1_3_3_9_2","unstructured":"Food and Drug Administration. AJOVY\u00ae (fremanezumab). Available from: https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761089s013lbl.pdf (2021 accessed November 2025)."},{"key":"e_1_3_3_10_2","unstructured":"European Medicines Agency. AJOVY\u00ae (fremanezumab). 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