Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study
Identifieur interne : 000540 ( Istex/Corpus ); précédent : 000539; suivant : 000541Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study
Auteurs : Daniel Truong ; Drake D. Duane ; Joseph Jankovic ; Carlos Singer ; Lauren C. Seeberger ; Cynthia L. Comella ; Mark F. Lew ; Robert L. Rodnitzky ; Fabio O. Danisi ; James P. Sutton ; P. David Charles ; Robert A. Hauser ; Geoffrey L. SheeanSource :
- Movement Disorders [ 0885-3185 ] ; 2005-07.
English descriptors
Abstract
Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; P ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society
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DOI: 10.1002/mds.20403
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ISTEX:785AEE453336E9A6EC95C5F114B38ED80E086F39Le document en format XML
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Rodnitzky</name><affiliation><mods:affiliation>University of Iowa, Iowa City, Iowa, USA</mods:affiliation></affiliation></author><author><name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O." last="Danisi">Fabio O. Danisi</name><affiliation><mods:affiliation>Mount Sinai Medical Center, New York, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P." last="Sutton">James P. Sutton</name><affiliation><mods:affiliation>Neurological Research Institute, Encino, California, USA</mods:affiliation></affiliation></author><author><name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P. David" last="Charles">P. David Charles</name><affiliation><mods:affiliation>Vanderbilt University, Nashville, Tennessee, USA</mods:affiliation></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation><mods:affiliation>University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation></author><author><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L." last="Sheean">Geoffrey L. Sheean</name><affiliation><mods:affiliation>University of California, San Diego, California, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2005-07">2005-07</date><biblScope unit="vol">20</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="783">783</biblScope><biblScope unit="page" to="791">791</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">785AEE453336E9A6EC95C5F114B38ED80E086F39</idno><idno type="DOI">10.1002/mds.20403</idno><idno type="ArticleID">MDS20403</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Dysport</term><term>botulinum toxin</term><term>cervical dystonia</term><term>clinical trial</term><term>spasmodic torticollis</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; P ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Daniel Truong MD</name><affiliations><json:string>The Parkinson's and Movement Disorders Institute, Fountain Valley, California, USA</json:string></affiliations></json:item><json:item><name>Drake D. Duane MD</name><affiliations><json:string>Arizona Dystonia Institute, Scottsdale, Arizona, USA</json:string></affiliations></json:item><json:item><name>Joseph Jankovic MD</name><affiliations><json:string>Baylor College of Medicine, Houston, Texas, USA</json:string></affiliations></json:item><json:item><name>Carlos Singer MD</name><affiliations><json:string>University of Miami School of Medicine, Miami, Florida, USA</json:string></affiliations></json:item><json:item><name>Lauren C. Seeberger MD</name><affiliations><json:string>Colorado Neurological Institute, Englewood, Colorado, USA</json:string></affiliations></json:item><json:item><name>Cynthia L. Comella MD</name><affiliations><json:string>Rush University Medical Center, Chicago, Illinois, USA</json:string></affiliations></json:item><json:item><name>Mark F. Lew MD</name><affiliations><json:string>University of Southern California, Los Angeles, California, USA</json:string></affiliations></json:item><json:item><name>Robert L. Rodnitzky MD</name><affiliations><json:string>University of Iowa, Iowa City, Iowa, USA</json:string></affiliations></json:item><json:item><name>Fabio O. Danisi MD</name><affiliations><json:string>Mount Sinai Medical Center, New York, New York, USA</json:string></affiliations></json:item><json:item><name>James P. Sutton MD</name><affiliations><json:string>Neurological Research Institute, Encino, California, USA</json:string></affiliations></json:item><json:item><name>P. David Charles MD</name><affiliations><json:string>Vanderbilt University, Nashville, Tennessee, USA</json:string></affiliations></json:item><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Geoffrey L. Sheean MD</name><affiliations><json:string>University of California, San Diego, California, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>cervical dystonia</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>spasmodic torticollis</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>botulinum toxin</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Dysport</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>clinical trial</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; P ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society</abstract><qualityIndicators><score>7.485</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1419</abstractCharCount><pdfWordCount>4905</pdfWordCount><pdfCharCount>31590</pdfCharCount><pdfPageCount>9</pdfPageCount><abstractWordCount>215</abstractWordCount></qualityIndicators><title>Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study</title><genre><json:string>Serial article</json:string></genre><host><volume>20</volume><pages><total>9</total><last>791</last><first>783</first></pages><issn><json:string>0885-3185</json:string></issn><issue>7</issue><subject><json:item><value>Research 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xml:lang="en">Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>2005</date></publicationStmt><notesStmt><note>Beauford Ipsen</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study</title><author><persName><forename type="first">Daniel</forename><surname>Truong</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: The Parkinson's and Movement Disorders Institute, 9940 Talbert Avenue #204, Fountain Valley, CA 92708</p></note><affiliation>The Parkinson's and Movement Disorders Institute, Fountain Valley, California, USA</affiliation></author><author><persName><forename type="first">Drake D.</forename><surname>Duane</surname><roleName type="degree">MD</roleName></persName><affiliation>Arizona Dystonia Institute, Scottsdale, Arizona, USA</affiliation></author><author><persName><forename type="first">Joseph</forename><surname>Jankovic</surname><roleName type="degree">MD</roleName></persName><affiliation>Baylor College of Medicine, Houston, Texas, USA</affiliation></author><author><persName><forename type="first">Carlos</forename><surname>Singer</surname><roleName type="degree">MD</roleName></persName><affiliation>University of Miami School of Medicine, Miami, Florida, USA</affiliation></author><author><persName><forename type="first">Lauren C.</forename><surname>Seeberger</surname><roleName type="degree">MD</roleName></persName><affiliation>Colorado Neurological Institute, Englewood, Colorado, USA</affiliation></author><author><persName><forename type="first">Cynthia L.</forename><surname>Comella</surname><roleName type="degree">MD</roleName></persName><affiliation>Rush University Medical Center, Chicago, Illinois, USA</affiliation></author><author><persName><forename type="first">Mark F.</forename><surname>Lew</surname><roleName type="degree">MD</roleName></persName><affiliation>University of Southern California, Los Angeles, California, USA</affiliation></author><author><persName><forename type="first">Robert L.</forename><surname>Rodnitzky</surname><roleName type="degree">MD</roleName></persName><affiliation>University of Iowa, Iowa City, Iowa, USA</affiliation></author><author><persName><forename type="first">Fabio O.</forename><surname>Danisi</surname><roleName type="degree">MD</roleName></persName><affiliation>Mount Sinai Medical Center, New York, New York, USA</affiliation></author><author><persName><forename type="first">James P.</forename><surname>Sutton</surname><roleName type="degree">MD</roleName></persName><affiliation>Neurological Research Institute, Encino, California, USA</affiliation></author><author><persName><forename type="first">P. David</forename><surname>Charles</surname><roleName type="degree">MD</roleName></persName><affiliation>Vanderbilt University, Nashville, Tennessee, USA</affiliation></author><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname><roleName type="degree">MD</roleName></persName><affiliation>University of South Florida, Tampa, Florida, USA</affiliation></author><author><persName><forename type="first">Geoffrey L.</forename><surname>Sheean</surname><roleName type="degree">MD</roleName></persName><affiliation>University of California, San Diego, California, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2005-07"></date><biblScope unit="vol">20</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="783">783</biblScope><biblScope unit="page" to="791">791</biblScope></imprint></monogr><idno type="istex">785AEE453336E9A6EC95C5F114B38ED80E086F39</idno><idno type="DOI">10.1002/mds.20403</idno><idno type="ArticleID">MDS20403</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2005</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; P ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>cervical dystonia</term></item><item><term>spasmodic torticollis</term></item><item><term>botulinum toxin</term></item><item><term>Dysport</term></item><item><term>clinical trial</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2003-12-12">Received</change><change when="2004-07-20">Registration</change><change when="2005-07">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/785AEE453336E9A6EC95C5F114B38ED80E086F39/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="70"><doi origin="wiley" registered="yes">10.1002/mds.v20:7</doi><numberingGroup><numbering type="journalVolume" number="20">20</numbering><numbering type="journalIssue">7</numbering></numberingGroup><coverDate startDate="2005-07">July 2005</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="20" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.20403</doi><idGroup><id type="unit" value="MDS20403"></id></idGroup><countGroup><count type="pageTotal" number="9"></count></countGroup><titleGroup><title type="articleCategory">Research Article</title><title type="tocHeading1">Research Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 2005 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2003-12-12"></event><event type="manuscriptRevised" date="2004-05-20"></event><event type="manuscriptAccepted" date="2004-07-20"></event><event type="publishedOnlineEarlyUnpaginated" date="2005-02-25"></event><event type="firstOnline" date="2005-02-25"></event><event type="publishedOnlineFinalForm" date="2005-07-05"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.3.2 mode:FullText source:FullText result:FullText" date="2010-03-09"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-02"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-31"></event></eventGroup><numberingGroup><numbering type="pageFirst">783</numbering><numbering type="pageLast">791</numbering></numberingGroup><correspondenceTo>The Parkinson's and Movement Disorders Institute, 9940 Talbert Avenue #204, Fountain Valley, CA 92708</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS20403.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="1"></count><count type="tableTotal" number="5"></count><count type="referenceTotal" number="19"></count><count type="wordTotal" number="5708"></count></countGroup><titleGroup><title type="main" xml:lang="en">Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study</title><title type="short" xml:lang="en">Dysport for Cervical Dystonia</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Daniel</givenNames><familyName>Truong</familyName><degrees>MD</degrees></personName><contactDetails><email>dtruong@pmdi.org</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Drake D.</givenNames><familyName>Duane</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Joseph</givenNames><familyName>Jankovic</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Carlos</givenNames><familyName>Singer</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Lauren C.</givenNames><familyName>Seeberger</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Cynthia L.</givenNames><familyName>Comella</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Mark F.</givenNames><familyName>Lew</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Robert L.</givenNames><familyName>Rodnitzky</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af9"><personName><givenNames>Fabio O.</givenNames><familyName>Danisi</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au10" creatorRole="author" affiliationRef="#af10"><personName><givenNames>James P.</givenNames><familyName>Sutton</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au11" creatorRole="author" affiliationRef="#af11"><personName><givenNames>P. David</givenNames><familyName>Charles</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au12" creatorRole="author" affiliationRef="#af12"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au13" creatorRole="author" affiliationRef="#af13"><personName><givenNames>Geoffrey L.</givenNames><familyName>Sheean</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>The Parkinson's and Movement Disorders Institute, Fountain Valley, California, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Arizona Dystonia Institute, Scottsdale, Arizona, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Baylor College of Medicine, Houston, Texas, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>University of Miami School of Medicine, Miami, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Colorado Neurological Institute, Englewood, Colorado, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="US" type="organization"><unparsedAffiliation>Rush University Medical Center, Chicago, Illinois, USA</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="US" type="organization"><unparsedAffiliation>University of Southern California, Los Angeles, California, USA</unparsedAffiliation></affiliation><affiliation xml:id="af8" countryCode="US" type="organization"><unparsedAffiliation>University of Iowa, Iowa City, Iowa, USA</unparsedAffiliation></affiliation><affiliation xml:id="af9" countryCode="US" type="organization"><unparsedAffiliation>Mount Sinai Medical Center, New York, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af10" countryCode="US" type="organization"><unparsedAffiliation>Neurological Research Institute, Encino, California, USA</unparsedAffiliation></affiliation><affiliation xml:id="af11" countryCode="US" type="organization"><unparsedAffiliation>Vanderbilt University, Nashville, Tennessee, USA</unparsedAffiliation></affiliation><affiliation xml:id="af12" countryCode="US" type="organization"><unparsedAffiliation>University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af13" countryCode="US" type="organization"><unparsedAffiliation>University of California, San Diego, California, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">cervical dystonia</keyword><keyword xml:id="kwd2">spasmodic torticollis</keyword><keyword xml:id="kwd3">botulinum toxin</keyword><keyword xml:id="kwd4">Dysport</keyword><keyword xml:id="kwd5">clinical trial</keyword></keywordGroup><fundingInfo><fundingAgency>Beauford Ipsen</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; <i>P</i> ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 4-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Dysport for Cervical Dystonia</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study</title></titleInfo><name type="personal"><namePart type="given">Daniel</namePart><namePart type="family">Truong</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>The Parkinson's and Movement Disorders Institute, Fountain Valley, California, USA</affiliation><description>Correspondence: The Parkinson's and Movement Disorders Institute, 9940 Talbert Avenue #204, Fountain Valley, CA 92708</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Drake D.</namePart><namePart type="family">Duane</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Arizona Dystonia Institute, Scottsdale, Arizona, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joseph</namePart><namePart type="family">Jankovic</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Baylor College of Medicine, Houston, Texas, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Carlos</namePart><namePart type="family">Singer</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>University of Miami School of Medicine, Miami, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lauren C.</namePart><namePart type="family">Seeberger</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Colorado Neurological Institute, Englewood, Colorado, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Cynthia L.</namePart><namePart type="family">Comella</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Rush University Medical Center, Chicago, Illinois, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mark F.</namePart><namePart type="family">Lew</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>University of Southern California, Los Angeles, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert L.</namePart><namePart type="family">Rodnitzky</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>University of Iowa, Iowa City, Iowa, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Fabio O.</namePart><namePart type="family">Danisi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Mount Sinai Medical Center, New York, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">James P.</namePart><namePart type="family">Sutton</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Neurological Research Institute, Encino, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P. David</namePart><namePart type="family">Charles</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Vanderbilt University, Nashville, Tennessee, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Geoffrey L.</namePart><namePart type="family">Sheean</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>University of California, San Diego, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2005-07</dateIssued><dateCaptured encoding="w3cdtf">2003-12-12</dateCaptured><dateValid encoding="w3cdtf">2004-07-20</dateValid><copyrightDate encoding="w3cdtf">2005</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">1</extent><extent unit="tables">5</extent><extent unit="references">19</extent><extent unit="words">5708</extent></physicalDescription><abstract lang="en">Botulinum toxin type A (Dysport) has been shown in European studies to be a safe and effective treatment for cervical dystonia. This multicenter, double‐blind, randomized, controlled trial assessed the safety and efficacy of Dysport in cervical dystonia patients in the United States. Eighty patients were randomly assigned to receive one treatment with Dysport (500 units) or placebo. Participants were followed up for 4 to 20 weeks, until they needed further treatment. They were assessed at baseline and weeks 2, 4, 8, 12, 16, and 20 after treatment. Dysport was significantly more efficacious than placebo at weeks 4, 8, and 12 as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (10‐point vs. 3.8‐point reduction in total score, respectively, at week 4; P ≤ 0.013). Of participants in the Dysport group, 38% showed positive treatment response, compared to 16% in the placebo group (95% confidence interval, 0.02–0.41). The median duration of response to Dysport was 18.5 weeks. Side effects were generally similar in the two treatment groups; only blurred vision and weakness occurred significantly more often with Dysport. No participants in the Dysport group converted from negative to positive antibodies after treatment. These results confirm previous reports that Dysport (500 units) is safe, effective, and well‐tolerated in patients with cervical dystonia. © 2005 Movement Disorder Society</abstract><note type="funding">Beauford Ipsen</note><subject lang="en"><genre>Keywords</genre><topic>cervical dystonia</topic><topic>spasmodic torticollis</topic><topic>botulinum toxin</topic><topic>Dysport</topic><topic>clinical trial</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2005</date><detail type="volume"><caption>vol.</caption><number>20</number></detail><detail type="issue"><caption>no.</caption><number>7</number></detail><extent unit="pages"><start>783</start><end>791</end><total>9</total></extent></part></relatedItem><identifier type="istex">785AEE453336E9A6EC95C5F114B38ED80E086F39</identifier><identifier type="DOI">10.1002/mds.20403</identifier><identifier type="ArticleID">MDS20403</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2005 Movement Disorder Society</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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