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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cervical Dystonia

In brief

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.

Key facts

Study ID

NCT01753310

Run by

Ipsen

People needed

134

Starts

2013-01-01

Expected to finish

2015-01-01

Last updated by the study team

2019-08-07

Who can join

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

You may qualify if…

• Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
• TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

You may not qualify if…

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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Movement Disorders Center of Arizona, LLC — Scottsdale, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• East Bay Physician's Group — Berkeley, California, United States
• Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• Loma Linda University Healthcare, Department of Neurology — Loma Linda, California, United States
• USC Keck School of Medicine — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of Colorado at Denver Health Sciences — Aurora, Colorado, United States
• Advanced Neurosciences Research — Fort Collins, Colorado, United States
• Associated Neurologists of Southern Connecticut — Fairfield, Connecticut, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Parkinson's & Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• University of Florida Center for Movement Disorders and Neurorestoration — Gainesville, Florida, United States
• Emerald Coast Center for Neurological Disorders — Pensacola, Florida, United States
• PD Treatment Center of SW FL — Port Charlotte, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Guilford Neurologic Associates — West Palm Beach, Florida, United States
• Premiere Research Institute at Palm Beach Neurology — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• NeuroTrials Research Inc. — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Kansas City Bone & Joint Clinic — Kansas City, Kansas, United States
• International Clinical Research Institute — Overland Park, Kansas, United States
• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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