Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

Last updated: July 25, 2019
Sponsor: Ipsen
Overall Status: Completed

Phase

3

Condition

Neck Pain

Dystonia

Dystonias

Treatment

N/A

Clinical Study ID

NCT01753310
A-TL-52120-169
  • Ages > 18
  • All Genders

Study Summary

The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Primary diagnosis of Cervical Dystonia at least 9 months since onset and eitherpreviously untreated with botulinum toxin or currently treated with Botox at a totaldosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the lastinjection cycle, and having had a satisfactory treatment response in the principalinvestigator's judgment during the last two sequential Botox treatment cycles.

  • TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion

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 Botoxtreatments

  • Known requirement of <100U or >200U of Botox injected into the neck muscles

Study Design

Total Participants: 134
Study Start date:
January 01, 2013
Estimated Completion Date:
January 31, 2015

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Movement Disorders Center of Arizona, LLC

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • University of Arizona

    Tucson, Arizona 85724
    United States

    Site Not Available

  • East Bay Physician's Group

    Berkeley, California 94705
    United States

    Site Not Available

  • Parkinson's and Movement Disorder Institute

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Loma Linda University Healthcare, Department of Neurology

    Loma Linda, California 92354
    United States

    Site Not Available

  • USC Keck School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of Colorado at Denver Health Sciences

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Advanced Neurosciences Research

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Associated Neurologists of Southern Connecticut

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Yale Medical Group, Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Parkinson's & Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • University of Florida Center for Movement Disorders and Neurorestoration

    Gainesville, Florida 32607
    United States

    Site Not Available

  • Emerald Coast Center for Neurological Disorders

    Pensacola, Florida 32514
    United States

    Site Not Available

  • PD Treatment Center of SW FL

    Port Charlotte, Florida 33980
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • Guilford Neurologic Associates

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • NeuroTrials Research Inc.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Kansas City Bone & Joint Clinic

    Kansas City, Kansas 66211
    United States

    Site Not Available

  • International Clinical Research Institute

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Rehabilitation Consultants PA

    Eagan, Minnesota 55122
    United States

    Site Not Available

  • University of Medicine and Dentistry of New Jersey

    Stratford, New Jersey 08084
    United States

    Site Not Available

  • Atlantic Neuroscience Institute

    Summit, New Jersey 07901
    United States

    Site Not Available

  • Kingston Neurological Associates

    Kingston, New York 12401
    United States

    Site Not Available

  • Fazzini Parkinson's Disease & Dystonia Center

    New York, New York 10016
    United States

    Site Not Available

  • The Ichan School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Island Neurological Associates

    Plainview, New York 11803
    United States

    Site Not Available

  • Guilford Neurologic Associates; Cone Health Medical Group

    Greensboro, North Carolina 27405
    United States

    Site Not Available

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Cincinnati Physicians Company, LLC

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • OHSU Center for Health and Healing

    Portland, Oregon 97239
    United States

    Site Not Available

  • Penn State Hershey Neurology

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Coastal Neurology

    Port Royal, South Carolina 29935
    United States

    Site Not Available

  • North Texas Movement Disorders Institute

    Bedford, Texas 76201
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Puget Sound Neurology

    Tacoma, Washington 98409
    United States

    Site Not Available

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