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
We found this trial at
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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201 Dowman Dr
Atlanta, Georgia 30308
404.727.6123
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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7000 Fannin St
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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Sacramento, California 95814
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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1653 W. Congress Parkway
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Eagan, Minnesota 55121
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Kansas City, Kansas 66211
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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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Tacoma, Washington 98409
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Tucson, Arizona 85721
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
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West Palm Beach, Florida 33407
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