Last updated on June 2019

Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Adult Upper Limb Spasticity

Brief description of study

This is a randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Ranging, trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Upper Limb Spasticity in Adults After Stroke or Traumatic Brain Injury. The study will be conducted in the U.S.A. , approximately 128 adult subjects from approximately 30 study centers will be randomly assigned (1:1:1:1) to one of four treatment groups. The study consists of a 21-day screening period, a treatment visit and follow-up visits. The study is expected to last approximately 2 years, and the duration of individual subject participation will vary.

Detailed Study Description

Subjects will be randomly assigned to DAXI for Injection high dose, DAXI for Injection medium dose, DAXI for Injection low dose, or placebo group, respectively. Eligible subjects will have ULS characterized by a primary aggregate posture

Clinical Study Identifier: NCT03821402

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Kansas Institute of Research

Overland Park, KS United States
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Waterbury Neurologists

Middlebury, CT United States
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William Beaumont Hospital

Royal Oak, MO United States
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Rusk Rehabilitation Hospital

Columbia Falls, MT United States
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Atrium Health

Charlotte, NC United States
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Recruitment Status: Open

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