{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,5]],"date-time":"2026-02-05T09:28:16Z","timestamp":1770283696293,"version":"3.49.0"},"reference-count":29,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T00:00:00Z","timestamp":1748476800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015516","name":"Revance","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015516","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["movementdisorders.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Movement Disord Clin Pract"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>DaxibotulinumtoxinA (DAXI), a novel botulinum neurotoxin (BoNT) formulation, was shown to be safe, effective, and long\u2010lasting in the treatment of cervical dystonia (CD) over one treatment cycle in the phase 3, randomized, placebo\u2010controlled ASPEN\u20101 trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the safety, immunogenicity, and efficacy of repeat DAXI treatments for CD over 52\u2009weeks in the phase 3, open\u2010label ASPEN\u2010OLS (NCT03617367).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Adults with moderate\u2010to\u2010severe CD (Toronto Western Spasmodic Torticollis Rating Scale [TWSTRS] score\u2009\u226520) initially received DAXI 125U or 250U based on treatment history and investigator judgment. Retreatment could be titrated (50U\u201075U) each cycle (maximum 300U) for up to four\u2009cycles over 52\u2009weeks. Assessments were conducted at Week 4, 6, 12, and every 4\u2009weeks until retreatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In all, 357 subjects received \u22651 dose of DAXI; most subjects (68.9%) received 250U during Cycle 1. Subjects most commonly received three (47.3%) or two (26.6%) treatments over 52\u2009weeks. The average dose increased with successive cycles (Cycle 2: 239U, Cycle 3: 256U, Cycle 4: 270U). Mean (SD) change in TWSTRS score from baseline increased from \u221215.4 (10.3) in Cycle 1 to \u221219.9 (13.6) in Cycle 4. Median duration of effect was 20.1\u2009weeks (Cycle 1, 2). No trend was observed between exposure to DAXI and any safety signals or antibody events. The most frequently reported treatment\u2010related adverse events per treatment were muscular weakness (4.9%), injection\u2010site pain (4.2%), and dysphagia (3.9%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>DAXI was safe and efficacious over repeated treatments in adults with CD. Adverse event rates were similar to or potentially lower compared with conventional BoNTs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/mdc3.70104","type":"journal-article","created":{"date-parts":[[2025,5,29]],"date-time":"2025-05-29T05:54:42Z","timestamp":1748498082000},"page":"1764-1773","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Long\u2010Term Safety and Efficacy of Repeat Treatments with\n                    <scp>DaxibotulinumtoxinA<\/scp>\n                    in Cervical Dystonia: Results from the\n                    <scp>ASPEN<\/scp>\n                    \u2010Open\u2010Label Study"],"prefix":"10.1002","volume":"12","author":[{"given":"Peter","family":"McAllister","sequence":"first","affiliation":[{"name":"New England Institute for Neurology and Headache  Stamford Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atul T.","family":"Patel","sequence":"additional","affiliation":[{"name":"Kansas City Bone &amp; Joint Clinic  Overland Park Kansas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marta","family":"Banach","sequence":"additional","affiliation":[{"name":"Jagiellonian University  Krakow Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron","family":"Ellenbogen","sequence":"additional","affiliation":[{"name":"Quest Research Institute  Farmington Hills Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaroslaw","family":"Slawek","sequence":"additional","affiliation":[{"name":"Department of Neurological\u2010Psychiatric Nursing, Faculty of Health Sciences Medical University of Gdansk  Gda\u0144sk Poland"},{"name":"Neurology and Stroke Department St. Adalbert Hospital  Gda\u0144sk Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian","family":"Paus","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Bonn  Bonn Germany"},{"name":"Department of Neurology GFO Kliniken Troisdorf  Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hyder A.","family":"Jinnah","sequence":"additional","affiliation":[{"name":"Emory University School of Medicine  Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6341-6933","authenticated-orcid":false,"given":"Virgilio","family":"Evidente","sequence":"additional","affiliation":[{"name":"Movement Disorders Center of Arizona  Scottsdale Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5482-5313","authenticated-orcid":false,"given":"Todd M.","family":"Gross","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc.  Nashville Tennessee USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rashid","family":"Kazerooni","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc.  Nashville Tennessee USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5488-6594","authenticated-orcid":false,"given":"Conor J.","family":"Gallagher","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc.  Nashville Tennessee USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David A.","family":"Hollander","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc.  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