Randomized, Placebo-Controlled Study of Botulinum Type A Toxin (Dysport®) for the Treatment of Cervical Dystonia

Condition(s) targeted: Cervical Dystonia

Intervention: Botulinum type A toxin (Dysport®) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Jean-Loic Robin, Study Director, Affiliation: Ipsen

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.

Official title: A Phase III Multicentre, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) - change from baseline at week 4

Secondary outcome: Subject Visual Analogue Pain Score and Subject Symptom Assessment - change from baseline at week 4

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status

- TWSTRS severity, disability and total scores meeting the defined criteria at baseline

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 know neutralizing antibodies to type A toxin

St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States

Parkinson's and Movement Disorder Institute, Fountain Valley, California, United States

USC School of Medicine, Los Angeles, California 90033, United States

University of Florida, Gainesville, Florida, United States

University of Miami, Miami, Florida, United States

Emory University, Atlanta, Georgia, United States

St Petersburg Pavlov State Medical University, St Petersburg 197022, Russian Federation

Scientific Research Institute of Neurology, RAMS, Moscow 123367, Russian Federation

Municipal Multi-Speciality Hospital #2, St Petersburg 194354, Russian Federation

Clinic "Cecil Plus", Moscow 125047, Russian Federation

Rush University Medical Center, Chicago, Illinois, United States

University of Iowa, Iowa City, Iowa, United States

University of Maryland Medical Center, Baltimore, Maryland, United States

Wayne State University Medical Center, Southfield, Michigan, United States

Albany Medical Center, Albany, New York, United States

Columbia University, New York, New York, United States

Beth Israel Medical Center, New York, New York 10003, United States

Wake Forest University, Winston Salem, North Carolina, United States

Allegeheny General, Pittsburgh, Pennsylvania, United States

Baylor College of Medicine, Houston, Texas, United States

University of Texas Southwest, Dallas, Texas, United States

Swedish Neuroscience, Seattle, Washington, United States

Starting date: October 2005
Ending date: September 2006
Last updated: July 23, 2007