{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,6]],"date-time":"2026-06-06T08:42:26Z","timestamp":1780735346470,"version":"3.54.1"},"reference-count":21,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2016,9,21]],"date-time":"2016-09-21T00:00:00Z","timestamp":1474416000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100014382","name":"Ipsen","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100014382","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Movement Disorders"],"published-print":{"date-parts":[[2016,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Approved botulinum toxin A products require reconstitution. AbobotulinumtoxinA solution for injection is a ready\u2010to\u2010use liquid formulation of abobotulinumtoxinA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>The objective of this study was to demonstrate the superior efficacy of abobotulinumtoxinA solution for injection to placebo and to test the noninferior efficacy of abobotulinumtoxinA solution for injection versus abobotulinumtoxinA (dry formulation) in cervical dystonia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This was a phase\u20103, multicenter, prospective, double\u2010blind, randomized, active, and placebo\u2010controlled study (N\u2009=\u2009369). Patients with cervical dystonia were randomized (3:3:1) to abobotulinumtoxinA solution for injection 500 U, abobotulinumtoxinA 500 U, or placebo. Following the double\u2010blind phase, patients received abobotulinumtoxinA solution for injection, open\u2010label, for up to 4 cycles. The primary outcome was change from baseline at week 4 of the Toronto Western Spasmodic Torticollis Rating Scale total score. Secondary measures included change from baseline or cycle baseline in Toronto Western Spasmodic Torticollis Rating Scale scores.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At week 4, both products were superior to placebo (Toronto Western Spasmodic Torticollis Rating Scale total score least square mean decrease from baseline, abobotulinumtoxinA solution for injection 500 U \u221212.5, abobotulinumtoxinA 500 U \u221214.0, placebo \u22123.9;\n                      <jats:italic>P<\/jats:italic>\n                      \u2009&lt;\u2009.0001 vs placebo). The noninferiority limit of 3 points in the Toronto Western Spasmodic Torticollis Rating Scale total score at week 4 was not met for abobotulinumtoxinA solution for injection versus abobotulinumtoxinA. Toronto Western Spasmodic Torticollis Rating Scale total score reductions were maintained for up to 4 cycles of abobotulinumtoxinA solution for injection open\u2010label follow\u2010up treatment. Safety profiles of abobotulinumtoxinA solution for injection and abobotulinumtoxinA were similar, with dysphagia and injection\u2010site pain the most frequent drug\u2010related adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although the predefined noninferiority criterion was not met, abobotulinumtoxinA solution for injection was similarly effective to freeze\u2010dried abobotulinumtoxinA in reducing Toronto Western Spasmodic Torticollis Rating Scale total scores with a similar safety profile. AbobotulinumtoxinA solution for injection efficacy was maintained with chronic open\u2010label treatment, and this novel formulation may add convenience as well as dosing accuracy to treatment with abobotulinumtoxinA. \u00a9 2016 International Parkinson and Movement Disorder Society<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/mds.26760","type":"journal-article","created":{"date-parts":[[2016,9,21]],"date-time":"2016-09-21T09:26:49Z","timestamp":1474450009000},"page":"1649-1657","source":"Crossref","is-referenced-by-count":42,"title":["Efficacy and safety of abobotulinumtoxinA liquid formulation in cervical dystonia: A randomized\u2010controlled trial"],"prefix":"10.1002","volume":"31","author":[{"given":"Werner","family":"Poewe","sequence":"first","affiliation":[{"name":"Department of Neurology Innsbruck Medical University\/University Hospital Innsbruck Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre","family":"Burbaud","sequence":"additional","affiliation":[{"name":"Department of Clinical Neurophysiology CHU de Bordeaux Bordeaux France"},{"name":"Institut des Maladies Neurod\u00e9g\u00e9n\u00e9ratives Universit\u00e9 de Bordeaux Bordeaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Castelnovo","sequence":"additional","affiliation":[{"name":"Department of Neurology University Hospital Caremeau Nimes France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfgang H.","family":"Jost","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Freiburg Freiburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andres O.","family":"Ceballos\u2010Baumann","sequence":"additional","affiliation":[{"name":"Sch\u00f6n Klinik M\u00fcnchen Schwabing, Department of Neurology Technische Universit\u00e4t M\u00fcnchen M\u00fcnchen Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marta","family":"Banach","sequence":"additional","affiliation":[{"name":"Department of Neurology Jagiellonian University Medical College Krak\u00f3w Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Potulska\u2010Chromik","sequence":"additional","affiliation":[{"name":"Department of Neurology Medical University of Warsaw Warsaw Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joaquim J.","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Unit, Instituto de Medicina Molecular, Faculty of Medicine University of Lisbon Lisbon Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katalin","family":"Bihari","sequence":"additional","affiliation":[{"name":"National Institute of Clinical Neurosciences Budapest Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edvard","family":"Ehler","sequence":"additional","affiliation":[{"name":"Department of Neurology County Hospital Pardubice Pardubice Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Bares","sequence":"additional","affiliation":[{"name":"1st Department of Neurology, Faculty of Medicine Masaryk University Brno Czech Republic"},{"name":"St Anne's University Hospital Brno Czech Republic"},{"name":"Department of Neurology, Medical School University of Minnesota Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lyudmyla A.","family":"Dzyak","sequence":"additional","affiliation":[{"name":"Dnipropetrovsk State Medical Academy, Dnipropetrovsk Regional Clinical Hospital Mechnykov Mechnykov Ukraine"},{"name":"Department of Neurology Zhovtneva Ploshcha Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna N.","family":"Belova","sequence":"additional","affiliation":[{"name":"Research Institute of Traumatology and Orthopaedics Nizhnyi Novgorod Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emmanuel","family":"Pham","sequence":"additional","affiliation":[{"name":"Ipsen Innovation Les Ulis France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenzhong Jerry","family":"Liu","sequence":"additional","affiliation":[{"name":"Ipsen Biopharmaceuticals Inc Basking Ridge New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Picaut","sequence":"additional","affiliation":[{"name":"Research Institute of Traumatology and Orthopaedics Nizhnyi Novgorod 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