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 : 003936 ( Main/Curation ); précédent : 003935; suivant : 003937Efficacy 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 [États-Unis] ; Drake D. Duane [États-Unis] ; Joseph Jankovic [États-Unis] ; Carlos Singer [États-Unis] ; Lauren C. Seeberger [États-Unis] ; Cynthia L. Comella [États-Unis] ; Mark F. Lew [États-Unis] ; Robert L. Rodnitzky [États-Unis] ; Fabio O. Danisi [États-Unis] ; James P. Sutton [États-Unis] ; P. David Charles [États-Unis] ; Robert A. Hauser [États-Unis] ; Geoffrey L. Sheean [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2005-07.
Descripteurs français
- Pascal (Inist)
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adult, Aged, Antibody Formation, Bontoxilysin, Botulinum Toxins, Type A (therapeutic use), Clinical trial, Disability Evaluation, Dose-Response Relationship, Drug, Double blind study, Double-Blind Method, Drug Evaluation, Dysport, Dystonia, Female, Follow-Up Studies, Humans, Male, Middle Aged, Nervous system diseases, Neuromuscular Agents (therapeutic use), Pain Measurement (methods), Patient Satisfaction, Placebo, Prospective Studies, Safety, Spasmodic torticollis, Time Factors, Torticollis (drug therapy), Torticollis (immunology), Treatment Outcome, United States, botulinum toxin, cervical dystonia, clinical trial, spasmodic torticollis.
- MESH :
- chemical , therapeutic use : Botulinum Toxins, Type A, Neuromuscular Agents.
- geographic : United States.
- drug therapy : Torticollis.
- immunology : Torticollis.
- methods : Pain Measurement.
- Adult, Aged, Antibody Formation, Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Drug Evaluation, Female, Follow-Up Studies, Humans, Male, Middle Aged, Patient Satisfaction, Prospective Studies, Time Factors, Treatment Outcome.
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
Url:
DOI: 10.1002/mds.20403
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: Pour aller vers cette notice dans l'étape Curation :000540
- to stream Istex, to step Curation: Pour aller vers cette notice dans l'étape Curation :000540
- to stream Istex, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :002346
- to stream PubMed, to step Corpus: Pour aller vers cette notice dans l'étape Curation :003124
- to stream PubMed, to step Curation: Pour aller vers cette notice dans l'étape Curation :003124
- to stream PubMed, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :003148
- to stream Ncbi, to step Merge: Pour aller vers cette notice dans l'étape Curation :001177
- to stream Ncbi, to step Curation: Pour aller vers cette notice dans l'étape Curation :001177
- to stream Ncbi, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :001177
- to stream Main, to step Merge: Pour aller vers cette notice dans l'étape Curation :005023
- to stream PascalFrancis, to step Corpus: Pour aller vers cette notice dans l'étape Curation :001E27
- to stream PascalFrancis, to step Curation: Pour aller vers cette notice dans l'étape Curation :000E94
- to stream PascalFrancis, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :001E62
- to stream Main, to step Merge: Pour aller vers cette notice dans l'étape Curation :005340
Links to Exploration step
ISTEX:785AEE453336E9A6EC95C5F114B38ED80E086F39Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title 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><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name>
</author>
<author><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D." last="Duane">Drake D. Duane</name>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation><country>États-Unis</country>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</affiliation>
</author>
<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
</author>
<author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. Seeberger</name>
</author>
<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
</author>
<author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L." last="Rodnitzky">Robert L. Rodnitzky</name>
</author>
<author><name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O." last="Danisi">Fabio O. Danisi</name>
</author>
<author><name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P." last="Sutton">James P. Sutton</name>
</author>
<author><name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P. David" last="Charles">P. David Charles</name>
</author>
<author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name>
</author>
<author><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L." last="Sheean">Geoffrey L. Sheean</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:785AEE453336E9A6EC95C5F114B38ED80E086F39</idno>
<date when="2005" year="2005">2005</date>
<idno type="doi">10.1002/mds.20403</idno>
<idno type="url">https://api.istex.fr/document/785AEE453336E9A6EC95C5F114B38ED80E086F39/fulltext/pdf</idno>
<idno type="wicri:Area/Istex/Corpus">000540</idno>
<idno type="wicri:Area/Istex/Curation">000540</idno>
<idno type="wicri:Area/Istex/Checkpoint">002346</idno>
<idno type="wicri:doubleKey">0885-3185:2005:Truong D:efficacy:and:safety</idno>
<idno type="wicri:source">PubMed</idno>
<idno type="RBID">pubmed:15736159</idno>
<idno type="wicri:Area/PubMed/Corpus">003124</idno>
<idno type="wicri:Area/PubMed/Curation">003124</idno>
<idno type="wicri:Area/PubMed/Checkpoint">003148</idno>
<idno type="wicri:Area/Ncbi/Merge">001177</idno>
<idno type="wicri:Area/Ncbi/Curation">001177</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">001177</idno>
<idno type="wicri:doubleKey">0885-3185:2005:Truong D:efficacy:and:safety</idno>
<idno type="wicri:Area/Main/Merge">005023</idno>
<idno type="wicri:source">INIST</idno>
<idno type="RBID">Pascal:05-0387870</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">001E27</idno>
<idno type="wicri:Area/PascalFrancis/Curation">000E94</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">001E62</idno>
<idno type="wicri:doubleKey">0885-3185:2005:Truong D:efficacy:and:safety</idno>
<idno type="wicri:Area/Main/Merge">005340</idno>
<idno type="wicri:Area/Main/Curation">003936</idno>
</publicationStmt>
<sourceDesc><biblStruct><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><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The Parkinson's and Movement Disorders Institute, Fountain Valley, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D." last="Duane">Drake D. Duane</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Arizona Dystonia Institute, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Baylor College of Medicine, Houston, Texas</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</affiliation>
</author>
<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Miami School of Medicine, Miami, Florida</wicri:regionArea>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. Seeberger</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Colorado Neurological Institute, Englewood, Colorado</wicri:regionArea>
<placeName><region type="state">Colorado</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Rush University Medical Center, Chicago, Illinois</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
<affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Southern California, Los Angeles, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
<settlement type="city">Los Angeles</settlement>
</placeName>
<orgName type="university">Université de Californie du Sud</orgName>
</affiliation>
</author>
<author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L." last="Rodnitzky">Robert L. Rodnitzky</name>
<affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Iowa, Iowa City, Iowa</wicri:regionArea>
<placeName><region type="state">Iowa</region>
<settlement type="city">Iowa City</settlement>
</placeName>
<orgName type="university">Université de l'Iowa</orgName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Mount Sinai Medical Center, New York, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Neurological Research Institute, Encino, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vanderbilt University, Nashville, Tennessee</wicri:regionArea>
<placeName><region type="state">Tennessee</region>
</placeName>
</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 wicri:level="4"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of South Florida, Tampa, Florida</wicri:regionArea>
<placeName><region type="state">Floride</region>
<settlement type="city">Tampa</settlement>
</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of California, San Diego, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</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>Adult</term>
<term>Aged</term>
<term>Antibody Formation</term>
<term>Bontoxilysin</term>
<term>Botulinum Toxins, Type A (therapeutic use)</term>
<term>Clinical trial</term>
<term>Disability Evaluation</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double blind study</term>
<term>Double-Blind Method</term>
<term>Drug Evaluation</term>
<term>Dysport</term>
<term>Dystonia</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Nervous system diseases</term>
<term>Neuromuscular Agents (therapeutic use)</term>
<term>Pain Measurement (methods)</term>
<term>Patient Satisfaction</term>
<term>Placebo</term>
<term>Prospective Studies</term>
<term>Safety</term>
<term>Spasmodic torticollis</term>
<term>Time Factors</term>
<term>Torticollis (drug therapy)</term>
<term>Torticollis (immunology)</term>
<term>Treatment Outcome</term>
<term>United States</term>
<term>botulinum toxin</term>
<term>cervical dystonia</term>
<term>clinical trial</term>
<term>spasmodic torticollis</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term>
<term>Neuromuscular Agents</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Torticollis</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Torticollis</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Pain Measurement</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Antibody Formation</term>
<term>Disability Evaluation</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Evaluation</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Patient Satisfaction</term>
<term>Prospective Studies</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Bontoxilysin</term>
<term>Dystonie</term>
<term>Essai clinique</term>
<term>Etude double insu</term>
<term>Placebo</term>
<term>Système nerveux pathologie</term>
<term>Sécurité</term>
<term>Torticolis spasmodique</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</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>
<double idat="0885-3185:2005:Truong D:efficacy:and:safety"><INIST><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name>
<affiliation wicri:level="2"><inist:fA14 i1="01"><s1>The Parkinson's and Movement Disorders Institute</s1>
<s2>Fountain Valley, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D." last="Duane">Drake D. Duane</name>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Arizona Dystonia Institute</s1>
<s2>Scottsdale, Arizona</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</affiliation>
</author>
<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
<affiliation wicri:level="2"><inist:fA14 i1="04"><s1>University of Miami School of Medicine</s1>
<s2>Miami, Florida</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. Seeberger</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Colorado Neurological Institute</s1>
<s2>Engiewood, Colorado</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Colorado</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
<affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Rush University Medical Center</s1>
<s2>Chicago, Illinois</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
<affiliation wicri:level="4"><inist:fA14 i1="07"><s1>University of Southern California</s1>
<s2>Los Angeles, California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
<settlement type="city">Los Angeles</settlement>
</placeName>
<orgName type="university">Université de Californie du Sud</orgName>
</affiliation>
</author>
<author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L." last="Rodnitzky">Robert L. Rodnitzky</name>
<affiliation wicri:level="4"><inist:fA14 i1="08"><s1>University of Iowa</s1>
<s2>Iowa City, Iowa</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Iowa</region>
<settlement type="city">Iowa City</settlement>
</placeName>
<orgName type="university">Université de l'Iowa</orgName>
</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 wicri:level="2"><inist:fA14 i1="09"><s1>Mount Sinai Medical Center</s1>
<s2>New York, New York</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</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 wicri:level="2"><inist:fA14 i1="10"><s1>Neurological Research Institute</s1>
<s2>Encino, California</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</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 wicri:level="2"><inist:fA14 i1="11"><s1>Vanderbilt University</s1>
<s2>Nashville, Tennessee</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Tennessee</region>
</placeName>
</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 wicri:level="4"><inist:fA14 i1="12"><s1>University of South Florida</s1>
<s2>Tampa, Florida</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Floride</region>
<settlement type="city">Tampa</settlement>
</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
</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 wicri:level="2"><inist:fA14 i1="13"><s1>University of California</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">05-0387870</idno>
<date when="2005">2005</date>
<idno type="stanalyst">PASCAL 05-0387870 INIST</idno>
<idno type="RBID">Pascal:05-0387870</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">001E27</idno>
<idno type="wicri:Area/PascalFrancis/Curation">000E94</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">001E62</idno>
<idno type="wicri:doubleKey">0885-3185:2005:Truong D:efficacy:and:safety</idno>
<idno type="wicri:Area/Main/Merge">005340</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name>
<affiliation wicri:level="2"><inist:fA14 i1="01"><s1>The Parkinson's and Movement Disorders Institute</s1>
<s2>Fountain Valley, California</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D." last="Duane">Drake D. Duane</name>
<affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Arizona Dystonia Institute</s1>
<s2>Scottsdale, Arizona</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation wicri:level="2"><inist:fA14 i1="03"><s1>Baylor College of Medicine</s1>
<s2>Houston, Texas</s2>
<s3>USA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Texas</region>
</placeName>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</affiliation>
</author>
<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
<affiliation wicri:level="2"><inist:fA14 i1="04"><s1>University of Miami School of Medicine</s1>
<s2>Miami, Florida</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. Seeberger</name>
<affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Colorado Neurological Institute</s1>
<s2>Engiewood, Colorado</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Colorado</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
<affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Rush University Medical Center</s1>
<s2>Chicago, Illinois</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
<affiliation wicri:level="4"><inist:fA14 i1="07"><s1>University of Southern California</s1>
<s2>Los Angeles, California</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
<settlement type="city">Los Angeles</settlement>
</placeName>
<orgName type="university">Université de Californie du Sud</orgName>
</affiliation>
</author>
<author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L." last="Rodnitzky">Robert L. Rodnitzky</name>
<affiliation wicri:level="4"><inist:fA14 i1="08"><s1>University of Iowa</s1>
<s2>Iowa City, Iowa</s2>
<s3>USA</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Iowa</region>
<settlement type="city">Iowa City</settlement>
</placeName>
<orgName type="university">Université de l'Iowa</orgName>
</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 wicri:level="2"><inist:fA14 i1="09"><s1>Mount Sinai Medical Center</s1>
<s2>New York, New York</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
</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 wicri:level="2"><inist:fA14 i1="10"><s1>Neurological Research Institute</s1>
<s2>Encino, California</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</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 wicri:level="2"><inist:fA14 i1="11"><s1>Vanderbilt University</s1>
<s2>Nashville, Tennessee</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Tennessee</region>
</placeName>
</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 wicri:level="4"><inist:fA14 i1="12"><s1>University of South Florida</s1>
<s2>Tampa, Florida</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Floride</region>
<settlement type="city">Tampa</settlement>
</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
</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 wicri:level="2"><inist:fA14 i1="13"><s1>University of California</s1>
<s2>San Diego, California</s2>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
<imprint><date when="2005">2005</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Bontoxilysin</term>
<term>Clinical trial</term>
<term>Double blind study</term>
<term>Dystonia</term>
<term>Nervous system diseases</term>
<term>Placebo</term>
<term>Safety</term>
<term>Spasmodic torticollis</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term>
<term>Dystonie</term>
<term>Torticolis spasmodique</term>
<term>Sécurité</term>
<term>Bontoxilysin</term>
<term>Etude double insu</term>
<term>Placebo</term>
<term>Essai clinique</term>
</keywords>
</textClass>
</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.</div>
</front>
</TEI>
</INIST>
<ISTEX><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title 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><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name>
</author>
<author><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D." last="Duane">Drake D. Duane</name>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation><country>États-Unis</country>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</affiliation>
</author>
<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
</author>
<author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. Seeberger</name>
</author>
<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
</author>
<author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L." last="Rodnitzky">Robert L. Rodnitzky</name>
</author>
<author><name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O." last="Danisi">Fabio O. Danisi</name>
</author>
<author><name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P." last="Sutton">James P. Sutton</name>
</author>
<author><name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P. David" last="Charles">P. David Charles</name>
</author>
<author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name>
</author>
<author><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L." last="Sheean">Geoffrey L. Sheean</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">ISTEX</idno>
<idno type="RBID">ISTEX:785AEE453336E9A6EC95C5F114B38ED80E086F39</idno>
<date when="2005" year="2005">2005</date>
<idno type="doi">10.1002/mds.20403</idno>
<idno type="url">https://api.istex.fr/document/785AEE453336E9A6EC95C5F114B38ED80E086F39/fulltext/pdf</idno>
<idno type="wicri:Area/Istex/Corpus">000540</idno>
<idno type="wicri:Area/Istex/Curation">000540</idno>
<idno type="wicri:Area/Istex/Checkpoint">002346</idno>
<idno type="wicri:doubleKey">0885-3185:2005:Truong D:efficacy:and:safety</idno>
<idno type="wicri:source">PubMed</idno>
<idno type="RBID">pubmed:15736159</idno>
<idno type="wicri:Area/PubMed/Corpus">003124</idno>
<idno type="wicri:Area/PubMed/Curation">003124</idno>
<idno type="wicri:Area/PubMed/Checkpoint">003148</idno>
<idno type="wicri:Area/Ncbi/Merge">001177</idno>
<idno type="wicri:Area/Ncbi/Curation">001177</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">001177</idno>
<idno type="wicri:doubleKey">0885-3185:2005:Truong D:efficacy:and:safety</idno>
<idno type="wicri:Area/Main/Merge">005023</idno>
</publicationStmt>
<sourceDesc><biblStruct><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><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>The Parkinson's and Movement Disorders Institute, Fountain Valley, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Duane, Drake D" sort="Duane, Drake D" uniqKey="Duane D" first="Drake D." last="Duane">Drake D. Duane</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Arizona Dystonia Institute, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Baylor College of Medicine, Houston, Texas</wicri:regionArea>
<placeName><region type="state">Texas</region>
</placeName>
<placeName><settlement type="city">Houston</settlement>
<region type="state">Texas</region>
</placeName>
<orgName type="university" n="3">Baylor College of Medicine</orgName>
</affiliation>
</author>
<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Miami School of Medicine, Miami, Florida</wicri:regionArea>
<placeName><region type="state">Floride</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. Seeberger</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Colorado Neurological Institute, Englewood, Colorado</wicri:regionArea>
<placeName><region type="state">Colorado</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
<affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Rush University Medical Center, Chicago, Illinois</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
<affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Southern California, Los Angeles, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
<settlement type="city">Los Angeles</settlement>
</placeName>
<orgName type="university">Université de Californie du Sud</orgName>
</affiliation>
</author>
<author><name sortKey="Rodnitzky, Robert L" sort="Rodnitzky, Robert L" uniqKey="Rodnitzky R" first="Robert L." last="Rodnitzky">Robert L. Rodnitzky</name>
<affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Iowa, Iowa City, Iowa</wicri:regionArea>
<placeName><region type="state">Iowa</region>
<settlement type="city">Iowa City</settlement>
</placeName>
<orgName type="university">Université de l'Iowa</orgName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Mount Sinai Medical Center, New York, New York</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Neurological Research Institute, Encino, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vanderbilt University, Nashville, Tennessee</wicri:regionArea>
<placeName><region type="state">Tennessee</region>
</placeName>
</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 wicri:level="4"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of South Florida, Tampa, Florida</wicri:regionArea>
<placeName><region type="state">Floride</region>
<settlement type="city">Tampa</settlement>
</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
</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 wicri:level="2"><country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of California, San Diego, California</wicri:regionArea>
<placeName><region type="state">Californie</region>
</placeName>
</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>Adult</term>
<term>Aged</term>
<term>Antibody Formation</term>
<term>Botulinum Toxins, Type A (therapeutic use)</term>
<term>Disability Evaluation</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Evaluation</term>
<term>Dysport</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neuromuscular Agents (therapeutic use)</term>
<term>Pain Measurement (methods)</term>
<term>Patient Satisfaction</term>
<term>Prospective Studies</term>
<term>Time Factors</term>
<term>Torticollis (drug therapy)</term>
<term>Torticollis (immunology)</term>
<term>Treatment Outcome</term>
<term>United States</term>
<term>botulinum toxin</term>
<term>cervical dystonia</term>
<term>clinical trial</term>
<term>spasmodic torticollis</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term>
<term>Neuromuscular Agents</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Torticollis</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Torticollis</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Pain Measurement</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Antibody Formation</term>
<term>Disability Evaluation</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Drug Evaluation</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Patient Satisfaction</term>
<term>Prospective Studies</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</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>
</double>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Main/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 003936 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Curation/biblio.hfd -nk 003936 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Santé |area= MovDisordV3 |flux= Main |étape= Curation |type= RBID |clé= ISTEX:785AEE453336E9A6EC95C5F114B38ED80E086F39 |texte= Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study }}
![]() | This area was generated with Dilib version V0.6.23. | ![]() |