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 : 005023 ( Main/Merge ); précédent : 005022; suivant : 005024Efficacy 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
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adult, Aged, Antibody Formation, Botulinum Toxins, Type A (therapeutic use), Disability Evaluation, Dose-Response Relationship, Drug, Double-Blind Method, Drug Evaluation, Dysport, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neuromuscular Agents (therapeutic use), Pain Measurement (methods), Patient Satisfaction, Prospective Studies, 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
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<term>Aged</term>
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<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>
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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><region type="state">Illinois</region>
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</affiliation>
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<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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<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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<wicri:regionArea>University of Iowa, Iowa City, Iowa</wicri:regionArea>
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<orgName type="university">Université de l'Iowa</orgName>
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<author><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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<author><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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<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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<wicri:regionArea>Vanderbilt University, Nashville, Tennessee</wicri:regionArea>
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</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>
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<placeName><region type="state">Floride</region>
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</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
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</author>
<author><name sortKey="Sheean, Geoffrey L" sort="Sheean, Geoffrey L" uniqKey="Sheean G" first="Geoffrey L." last="Sheean">Geoffrey L. Sheean</name>
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<placeName><region type="state">Californie</region>
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<series><title level="j">Movement Disorders</title>
<title level="j" type="sub">Official Journal of the Movement Disorder Society</title>
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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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<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="Seeberger, Lauren C" sort="Seeberger, Lauren C" uniqKey="Seeberger L" first="Lauren C" last="Seeberger">Lauren C. Seeberger</name>
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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 < or = 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>
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