Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

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

Phase

3

Condition

Dystonia

Dyskinesias

Neck Pain

Treatment

N/A

Clinical Study ID

NCT01753336
A-TL-52120-170
  • Ages > 18
  • All Genders

Study Summary

The purpose of the protocol is to assess the long term safety of repeat treatment cycles of Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an extension study to study A-TL-52120-169 (hereafter referred to as Study 169).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects enrolled in Study 169 that have no ongoing adverse events, which in theopinion of the Investigator are related to study treatment and that precludes themfrom receiving continuing therapy

  • Completed Study 169, or completed all study visits up to and including Week 4 and inthe event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS totalscore at Week 4 compared to their baseline TWSTRS total score in the double-blindstudy, and in the Investigator's clinical judgment, would benefit from Dysport® for CD

Exclusion

Exclusion Criteria:

  • Diagnosis of pure retrocollis or pure anterocollis

  • Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders otherthan CD and unable to avoid such treatment(s) for the duration of the study

  • Known hypersensitivity to BoNT or related compounds, or any component in the studydrug formulation

  • Allergy to cow's milk protein

  • Myasthenia gravis, other disease of the neuromuscular junction or clinicallysignificant, persistent neuromuscular weakness, or disease or symptoms that couldinterfere with the TWSTRS scoring

  • Total body weight <95 lbs (43.09 kg)

  • Previous phenol injections to the neck muscles

  • Previous myotomy or denervation surgery involving the neck or shoulder region or deepbrain stimulation to treat CD

  • Cervical contracture that limited passive range of motion

  • Physiotherapy initiated <4 weeks before study entry or expected to be initiated duringthe study

  • Treatment with aminoglycoside antibiotics within 30 days prior to study treatment

  • Current or expected requirement for concomitant medication that could interfere withthe evaluation of study treatment

  • Pregnant and/or lactating females

  • Females of childbearing potential with a positive prestudy urine pregnancy test (apositive urine pregnancy test could be confirmed by a serum pregnancy test at thediscretion of the investigator) and subjects, or their partners, who did not agree touse adequate contraception (hormonal or barrier method of birth control) prior toinjection of study treatment and for the duration of study participation.Nonchildbearing potential is defined as postmenopause for at least 1 year, surgicalsterilisation at least 3 months before entering the study, or hysterectomy

  • Individuals who had family or employee relationship to study site staff or sponsorstaff involved in the conduct of the study

  • Any medical condition that could, as judged by the investigator, compromise compliancewith the objectives and procedures of this protocol or preclude the administration ofBoNT, including swallowing and other respiratory abnormality.

  • Subjects who were unable and/or unwilling to comply fully with the protocol and thestudy instructions, as judged by the investigator

Study Design

Total Participants: 112
Study Start date:
March 01, 2013
Estimated Completion Date:
October 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

  • Sutter Cancer Center

    Sacramento, California 95816
    United States

    Site Not Available

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Advanced Neurosciences Research

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Associated Neurologist of Southern CT, PC

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • Yale Medical Group, Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Parkinson's Disease and 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

  • Parkinson's Treatment Center of SW Florida

    Port Charlotte, Florida 33980
    United States

    Site Not Available

  • USF HealthParkinson's Disease and Movement Disorders Center

    Tampa, Florida 33613
    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 55121
    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

  • 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, PA

    Port Royal, South Carolina 29935
    United States

    Site Not Available

  • Siskin Spine and Rehab

    Chattanooga, Tennessee
    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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