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

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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.


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
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Sacramento, California 95816
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
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201 Dowman Dr
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Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
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185 Cambridge Street
Boston, Massachusetts 02114
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800 Washington St
Boston, Massachusetts 02111
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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1200 Moursund Street
Houston, Texas 77030
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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
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University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Sacramento, California 95814
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4202 E Fowler Ave
Tampa, Florida 33620
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University of South Florida The University of South Florida is a high-impact, global research university...
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Aurora, CO
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Bedford, TX
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Berkeley, California 94705
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Boca Raton, FL
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1653 W. Congress Parkway
Chicago, Illinois 60612
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Eagan, Minnesota 55121
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Fort Collins, Colorado 80528
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Fountain Valley, California 92708
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Hershey, Pennsylvania
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Kansas City, Kansas 66211
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Kingston, New York 12401
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Los Angeles, California 90033
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New Haven, Connecticut 06520
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Plainview, New York 11803
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Port Charlotte, Florida 33980
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Port Royal, South Carolina 29935
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3303 Southwest Bond Avenue
Portland, Oregon 97239
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Scottsdale, Arizona 85258
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Summit, New Jersey 07901
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Tacoma, Washington 98409
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Tucson, Arizona 85721
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University of Arizona The University of Arizona is a premier, public research university. Established in...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
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Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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West Palm Beach, Florida 33407
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Winston-Salem, North Carolina 27157
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