{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T12:09:30Z","timestamp":1767182970208,"version":"build-2238731810"},"reference-count":9,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2021,2,1]],"date-time":"2021-02-01T00:00:00Z","timestamp":1612137600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013733","name":"Ipsen Biopharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100013733","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>\n                    Cervical dystonia (CD) is primarily treated with botulinum toxin, at intervals of \u2265 12 weeks. We present efficacy, patient-reported outcomes (PROs), and safety in adults with CD at the last available visit after a single set of abobotulinumtoxinA (aboBoNT-A) injections versus placebo using 500 U in a 2-mL injection volume. In this 12-week, randomized, double-blind trial, patients were \u2265 18 years of age with primary idiopathic CD, had a Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score \u2265 20, and TWSTRS-Severity subscale score &gt; 10 at baseline. Patients (N = 134) were randomized (2:1) to aboBoNT-A (n = 89) or placebo (n = 45), with aboBoNT-A patients treated with 500 units (U) if toxin-na\u00efve, and 250 to 500 U based on previous onabotulinumtoxinA dose if non-na\u00efve. Endpoints included total TWSTRS, Pain Numeric Rating Scale (NRS-Pain; 24-hour), Treatment Satisfaction Questionnaire for Medication, and other PROs for pain, depression, and global health. Results are for the intent-to-treat population, with \u201cWeek 12\u201d (Wk12) comprising the last available post-baseline assessment (end-of-study or early withdrawal). Mean TWSTRS total scores improved from 42.5 at baseline to 35.4 at Wk12 with aboBoNT-A and 42.4 to 40.4 with placebo (treatment difference: \u20134.8; 95% confidence interval [CI]: \u20138.5, \u20131.1;\n                    <jats:italic>p<\/jats:italic>\n                    = 0.011). At Wk12, mean (95% CI) change from baseline in NRS-Pain was \u20131.0 (\u20131.59, \u20130.45) for aboBoNT-A and \u20130.2 (\u20130.96, 0.65) for placebo. AboBoNT-A demonstrated numeric improvements in other PROs. More aboBoNT-A\u2013treated patients than patients receiving placebo reported being at least \u201csomewhat satisfied\u201d with treatment (60.4% vs 42.2%, respectively), symptom relief (57.0% vs 40.0%), and time for treatment to work (55.8% vs 33.3%). No new adverse events were reported. Results indicate that in patients with CD, treatment with aboBoNT-A using a 2-mL injection provided sustained improvement in the TWSTRS total score and patient-perceived benefits up to 12 weeks.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial registration:<\/jats:bold>\n                    Clinicaltrials.gov Identified:\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01753310\" xlink:type=\"simple\">NCT01753310<\/jats:ext-link>\n                    .\n                  <\/jats:p>","DOI":"10.1371\/journal.pone.0245827","type":"journal-article","created":{"date-parts":[[2021,2,1]],"date-time":"2021-02-01T15:10:17Z","timestamp":1612192217000},"page":"e0245827","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":5,"title":["Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study"],"prefix":"10.1371","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2765-7953","authenticated-orcid":true,"given":"Atul T.","family":"Patel","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark F.","family":"Lew","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Khashayar","family":"Dashtipour","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stuart","family":"Isaacson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert A.","family":"Hauser","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William","family":"Ondo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pascal","family":"Maisonobe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8838-6707","authenticated-orcid":true,"given":"Stefan","family":"Wietek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce","family":"Rubin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allison","family":"Brashear","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2021,2,1]]},"reference":[{"key":"pone.0245827.ref001","article-title":"Descriptive epidemiology of cervical dystonia","volume":"3","author":"G Defazio","year":"2013","journal-title":"Tremor Other Hyperkinet Mov (N Y)"},{"issue":"7","key":"pone.0245827.ref002","doi-asserted-by":"crossref","first-page":"926","DOI":"10.1002\/mds.25567","article-title":"The focal dystonias: current views and challenges for future research","volume":"28","author":"HA Jinnah","year":"2013","journal-title":"Mov Disord"},{"issue":"7","key":"pone.0245827.ref003","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1002\/mds.20403","article-title":"Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study","volume":"20","author":"D Truong","year":"2005","journal-title":"Mov Disord"},{"issue":"5","key":"pone.0245827.ref004","doi-asserted-by":"crossref","first-page":"316","DOI":"10.1016\/j.parkreldis.2010.03.002","article-title":"Long-term efficacy and safety of botulinum toxin type A (Dysport) in cervical dystonia","volume":"16","author":"D Truong","year":"2010","journal-title":"Parkinsonism Relat Disord"},{"issue":"2","key":"pone.0245827.ref005","doi-asserted-by":"crossref","first-page":"299","DOI":"10.1007\/s00702-012-0872-1","article-title":"AbobotulinumtoxinA (Dysport) dosing in cervical dystonia: an exploratory analysis of two large open-label extension studies","volume":"120","author":"RA Hauser","year":"2013","journal-title":"J Neural Transm (Vienna)"},{"key":"pone.0245827.ref006","unstructured":"Dysport [package insert]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.; 2019."},{"key":"pone.0245827.ref007","unstructured":"EMA List of Approved Medicinal Products. 2019. Active substance: botulinum toxin a\u2014haemagglutinin complex. Date accessed: 11\/4\/2020. Available from: https:\/\/www.ema.europa.eu\/en\/documents\/psusa\/botulinum-toxin-haemagglutinin-complex-list-nationally-authorised-medicinal-products-psusa\/00000427\/201812_en.pdf."},{"issue":"7","key":"pone.0245827.ref008","doi-asserted-by":"crossref","first-page":"619","DOI":"10.1080\/00207454.2017.1406935","article-title":"A 500 U\/2 mL dilution of abobotulinumtoxinA vs. placebo: randomized study in cervical dystonia","volume":"128","author":"MF Lew","year":"2018","journal-title":"Int J Neurosci"},{"issue":"3","key":"pone.0245827.ref009","doi-asserted-by":"crossref","first-page":"487","DOI":"10.1007\/s00702-012-0887-7","article-title":"Rating scales for cervical dystonia: a critical evaluation of tools for outcome assessment of botulinum toxin therapy","volume":"120","author":"WH Jost","year":"2013","journal-title":"J Neural Transm (Vienna)"}],"updated-by":[{"DOI":"10.1371\/journal.pone.0250475","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2021,4,14]],"date-time":"2021-04-14T00:00:00Z","timestamp":1618358400000}}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0245827","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,1]],"date-time":"2021-02-01T15:10:36Z","timestamp":1612192236000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0245827"}},"subtitle":[],"editor":[{"given":"Mandar S.","family":"Jog","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2021,2,1]]},"references-count":9,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2021,2,1]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0245827","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,2,1]]}}}