Last updated on June 2019

Single Treatment of DaxibotulinumtoxinA for Injection in Adults With Isolated Cervical Dystonia (ASPEN-1)

Brief description of study

This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of two doses of daxibotulinumtoxinA (DAXI) for injection (high-dose; low-dose in adult subjects with isolated (primary) cervical dystonia (CD).

Detailed Study Description

Approximately 300 subjects, recruited from approximately 80 study centers in the United States (US), Canada, and Europe will be randomized to DAXI for injection high dose, DAXI for injection low dose, or placebo group, respectively. Subjects will be stratified by treatment center and history of prior treatment with botulinum neurotoxin (BoNT).

Clinical Study Identifier: NCT03608397

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Suncoast Neuroscience Associates

Saint Petersburg, FL United States
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Infinity Clinical Research

Hollywood, FL United States
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Coastal Neurology

Port Royal, SC United States
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HOPE Research Institute

Phoenix, AZ United States
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Kansas Institute of Reseach

Overland Park, KS United States
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USC Keck School of Medicine

Los Angeles, CA United States
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Care Access Research

Pasadena, CA United States
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University of Miami

Miami, FL United States
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Emory University

Atlanta, GA United States
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Michigan State University

East Lansing, MI United States
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QUEST Research Institute

Farmington, MI United States
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Henry Ford West Bloomfield Hospital

West Bloomfield, MI United States
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St Louis University

Saint Louis, MO United States
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Washington University

Saint Louis, MO United States
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University of Rochester

Rochester, NY United States
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Wake Forest Health Sciences

Winston-Salem, NC United States
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Wesley Neurology Clinic

Cordova, TN United States
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Texas Neurology. P.A.

Dallas, TX United States
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Baylor College of Medicine

Houston, TX United States
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Recruitment Status: Open

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