MovDisordV3, Main, Curation, bibRecord, 003936

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 : 003937

Efficacy 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.

RBID : ISTEX:785AEE453336E9A6EC95C5F114B38ED80E086F39

Descripteurs français

Pascal (Inist)
- Bontoxilysin, Dystonie, Essai clinique, Etude double insu, Placebo, Système nerveux pathologie, Sécurité, Torticolis spasmodique.
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:

https://api.istex.fr/document/785AEE453336E9A6EC95C5F114B38ED80E086F39/fulltext/pdf

DOI: 10.1002/mds.20403

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Le document en format XML

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<term>Aged</term>
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<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>
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<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>
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<term>Torticolis spasmodique</term>
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<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>
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</placeName>
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</affiliation>
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<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>
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<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>
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</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>
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</inist:fA14>
<country>États-Unis</country>
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</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>
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</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Floride</region>
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</affiliation>
</author>
<author><name sortKey="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C." last="Seeberger">Lauren C. Seeberger</name>
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<placeName><region type="state">Colorado</region>
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</author>
<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
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<placeName><region type="state">Illinois</region>
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</author>
<author><name sortKey="Lew, Mark F" sort="Lew, Mark F" uniqKey="Lew M" first="Mark F." last="Lew">Mark F. Lew</name>
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<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>
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<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>
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<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>
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<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Tennessee</region>
</placeName>
</affiliation>
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<s2>Tampa, Florida</s2>
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<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Floride</region>
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</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>
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</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>
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<seriesStmt><title level="j" type="main">Movement disorders</title>
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<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>
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<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>
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<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>
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<author><name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
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<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>
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<wicri:regionArea>Arizona Dystonia Institute, Scottsdale, Arizona</wicri:regionArea>
<placeName><region type="state">Arizona</region>
</placeName>
</affiliation>
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<author><name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
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</affiliation>
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<orgName type="university">Université de Californie du Sud</orgName>
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<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>
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</placeName>
</affiliation>
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<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>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study

Efficacy and safety of botulinum type A toxin (Dysport) in cervical dystonia: Results of the first US randomized, double‐blind, placebo‐controlled study

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