Dysport® Adult Lower Limb Spasticity Study



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 80
Updated:12/13/2017
Start Date:March 2011
End Date:May 2014

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A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With 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 lower limb spasticity due to stroke or
traumatic brain injury.


Inclusion Criteria:

- Subjects aged 18 to 80 years of age

- Post stroke or brain injury

- Intensity of muscle tone greater than or equal to 2, as measured on the Modified
Ashworth Scale

- Ambulatory patients

Exclusion Criteria:

- Fixed contractures

- Physiotherapy initiated less than 4 weeks before entry

- Previous surgery or previous treatment with phenol and/or alcohol in lower limb

- Neurological/neuromuscular disorders which may interfere with protocol evaluations
We found this trial at
18
sites
13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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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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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Boca Raton, FL
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Downey, California 90242
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Elkins Park, Pennsylvania 19027
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Fairfield, Connecticut 06824
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Fairfield, CT
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Fort Worth, TX
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Houston, Texas 77030
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Houston, Texas 77098
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Houston, TX
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900 Park Centre Boulevard
Miami Gardens, Florida 33169
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Miami Gardens, FL
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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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New York, New York 10029
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New York, NY
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New York, New York 10021
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New York, NY
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Oxnard, CA
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89 Bridge Road
Richmond, Victoria 3121
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Richmond,
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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Winston-Salem, NC
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