MovDisordV3, Main, Exploration, 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/Exploration ); 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

Affiliations:

Le document en format XML

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<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>
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<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Torticollis</term>
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<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>
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<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>
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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>
</front>
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<li>Californie</li>
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<tree><country name="États-Unis"><region name="Californie"><name sortKey="Truong, Daniel" sort="Truong, Daniel" uniqKey="Truong D" first="Daniel" last="Truong">Daniel Truong</name>
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<name sortKey="Charles, P David" sort="Charles, P David" uniqKey="Charles P" first="P. David" last="Charles">P. David Charles</name>
<name sortKey="Comella, Cynthia L" sort="Comella, Cynthia L" uniqKey="Comella C" first="Cynthia L." last="Comella">Cynthia L. Comella</name>
<name sortKey="Danisi, Fabio O" sort="Danisi, Fabio O" uniqKey="Danisi F" first="Fabio O." last="Danisi">Fabio O. Danisi</name>
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<name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name>
<name sortKey="Jankovic, Joseph" sort="Jankovic, Joseph" uniqKey="Jankovic J" first="Joseph" last="Jankovic">Joseph Jankovic</name>
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<name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
<name sortKey="Sutton, James P" sort="Sutton, James P" uniqKey="Sutton J" first="James P." last="Sutton">James P. Sutton</name>
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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

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

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Pour manipuler ce document sous Unix (Dilib)

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	Movement Disorders (revue)
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.