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 |
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.
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
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
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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