A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD).
Status: | Completed |
---|---|
Conditions: | Neurology, Orthopedic, Women's Studies |
Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/8/2014 |
Start Date: | January 2013 |
End Date: | September 2014 |
Contact: | Ipsen Recruitment Enquiries |
Email: | clinical.trials@ipsen.com |
A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia.
The purpose of the protocol is to evaluate the efficacy of Dysport using 2 mL dilution
compared with placebo for the treatment of Cervical Dystonia.
compared with placebo for the treatment of Cervical Dystonia.
Inclusion Criteria:
- Primary diagnosis of Cervical Dystonia at least 9 months since onset and either
previously untreated with botulinum toxin or currently treated with Botox at a total
dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last
injection cycle, and having had a satisfactory treatment response in the principal
investigator's judgment during the last two sequential Botox treatment cycles.
- TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;
Exclusion Criteria:
- In apparent remission from Cervical Dystonia
- Diagnosis of pure retrocollis or pure anterocollis
- For non-naïve subjects, previous poor response to either of the last two Botox
treatments
- Known requirement of <100U or >200U of Botox injected into the neck muscles
We found this trial at
45
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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