Dysport® Adult Upper Limb Spasticity



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:August 2011
End Date:September 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

The purpose of this research study is to assess the efficacy of Dysport compared to placebo
in improving muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or
traumatic brain injury.


Inclusion Criteria:

- Adult patients - post stroke or brain injury

- Modified Ashworth Scale ≥ 2

- Ambulatory patients

Exclusion Criteria:

- Previous treatment with botulinum toxin of any type within 4 months prior to study
entry for any condition

- Physiotherapy initiated less than 4 weeks before inclusion

- Previous surgery, alcohol, phenol in upper limb

- Neurological/neuromuscular disorders which may interfere with protocol evaluations
We found this trial at
16
sites
Université catholique de Louvain av Hippocrate 10
Bruxelles,
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Bruxelles,
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida 33486
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Boca Raton, FL
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Rehabilitation Institute of Chicago
345 E Superior St
Chicago, Illinois 60611
(312) 238-1000
Rehabilitation Institute of Chicago The Rehabilitation Institute of Chicago (RIC) is an independent, 501(c)3, non-profit...
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Chicago, IL
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Southwestern Medical Center at Dallas
Dallas, Texas 75390
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Dallas, TX
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University of Texas
Dallas, Texas 75235
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Dallas, TX
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Rancho Los Amigos National Rehabilitation Center
Downey, California 90242
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Downey, CA
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Associated Neurologist of Southern CT, PT
Fairfield, Connecticut 06824
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Fairfield, CT
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University of North Texas HSC
Fort Worth, Texas 76104
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Fort Worth, TX
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The University Of Texas
Houston, Texas 77030
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Houston, TX
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Vanderbilt University
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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Mount Sinai School of Medicine
New York, New York 10029
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New York, NY
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Weill-Cornell Medical College
New York, New York 10021
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New York, NY
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University of Utah School of Medicine
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Design Neuroscience Miami
South Miami, Florida 33143
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South Miami, FL
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Wake Forest Medical Center
Winston Salem, North Carolina 27157
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from
Winston Salem, NC
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