Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

Last updated: September 15, 2022
Sponsor: Ipsen
Overall Status: Completed

Phase

3

Condition

Dystonias

Neck Pain

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT00257660
Y-47-52120-051
2005-000709-70
  • Ages > 18
  • All Genders

Study Summary

The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cervical dystonia with at least 18 months since onset, and previously untreated withbotulinum toxin or previously treated with botulinum toxin type A or B with a minimuminterval of 16 weeks since the last injection and having returned at least to theirusual pre-treatment status
  • TWSTRS severity, disability and total scores meeting the defined criteria at baseline

Exclusion

Exclusion Criteria:

  • Pure anterocollis or pure retrocollis
  • In apparent remission from cervical dystonia
  • Previous poor response to the last two botulinum toxin type A or type B treatments
  • Being treated with type B toxin due to lack of efficacy to type A toxin or have knownneutralizing antibodies to type A toxin

Study Design

Total Participants: 116
Study Start date:
October 10, 2005
Estimated Completion Date:
September 30, 2006

Connect with a study center

  • Clinic "Cecil Plus"

    Moscow, 125047
    Russian Federation

    Site Not Available

  • Scientific Research Institute of Neurology, RAMS

    Moscow, 123367
    Russian Federation

    Site Not Available

  • Municipal Multi-Speciality Hospital #2

    St Petersburg, 194354
    Russian Federation

    Site Not Available

  • St Petersburg Pavlov State Medical University

    St Petersburg, 197022
    Russian Federation

    Site Not Available

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona
    United States

    Site Not Available

  • Parkinson's and Movement Disorder Institute

    Fountain Valley, California
    United States

    Site Not Available

  • USC School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida
    United States

    Site Not Available

  • University of Miami

    Miami, Florida
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa
    United States

    Site Not Available

  • University of Maryland Medical Center

    Baltimore, Maryland
    United States

    Site Not Available

  • Wayne State University Medical Center

    Southfield, Michigan
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • Columbia University

    New York, New York
    United States

    Site Not Available

  • Wake Forest University

    Winston Salem, North Carolina
    United States

    Site Not Available

  • Wake Forest University

    Winston-Salem, North Carolina
    United States

    Site Not Available

  • Allegeheny General

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • University of Texas Southwest

    Dallas, Texas
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas
    United States

    Site Not Available

  • Swedish Neuroscience

    Seattle, Washington
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.