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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cervical Dystonia

In brief

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.

Key facts

Study ID

NCT00257660

Run by

Ipsen

People needed

116

Starts

2005-10-10

Expected to finish

2006-09-01

Last updated by the study team

2022-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 known neutralizing antibodies to type A toxin

Where it is running

• 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, United States
• University of Florida — Gainesville, Florida, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• 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
• Beth Israel Medical Center — New York, New York, United States
• Columbia University — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Allegeheny General — Pittsburgh, Pennsylvania, United States
• University of Texas Southwest — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Swedish Neuroscience — Seattle, Washington, United States
• Scientific Research Institute of Neurology, RAMS — Moscow, Russia
• Clinic "Cecil Plus" — Moscow, Russia
• Municipal Multi-Speciality Hospital #2 — Saint Petersburg, Russia
• St Petersburg Pavlov State Medical University — Saint Petersburg, Russia

Full record on ClinicalTrials.gov

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