Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic, Women's Studies |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2019 |
| Start Date: | October 2005 |
| End Date: | September 2006 |
A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport
manufactured at a new manufacturing facility in Europe.
manufactured at a new manufacturing facility in Europe.
Inclusion Criteria:
- Cervical dystonia with at least 18 months since onset, and previously untreated with
botulinum toxin or previously treated with botulinum toxin type A or B with a minimum
interval of 16 weeks since the last injection and having returned at least to their
usual pre-treatment status
- TWSTRS severity, disability and total scores meeting the defined criteria at baseline
Exclusion Criteria:
- Pure anterocollis or pure retrocollis
- In apparent remission from cervical dystonia
- Previous poor response to the last two botulinum toxin type A or type B treatments
- Being treated with type B toxin due to lack of efficacy to type A toxin or have known
neutralizing antibodies to type A toxin
We found this trial at
19
sites
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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University of Miami A private research university with more than 15,000 students from around the...
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Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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