BOTOX® Treatment in Pediatric Lower Limb Spasticity
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 2 - 16 |
| Updated: | 8/16/2018 |
| Start Date: | September 11, 2012 |
| End Date: | June 28, 2017 |
BOTOX® Treatment in Pediatric Lower Limb Spasticity: Double-blind Study
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in
pediatric patients with lower limb spasticity.
pediatric patients with lower limb spasticity.
Inclusion Criteria:
- Minimum weight of 10 kg/22 lb
- Cerebral palsy with dynamic muscle contracture /spasticity of the ankle
Exclusion Criteria:
- Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral
sclerosis, or mitochondrial disease
- Uncontrolled epilepsy
- Botulinum Toxin therapy of any serotype for any condition within the last 6 months
- History of surgical intervention of the lower study leg or planned surgery of any limb
during the study
- Previous casting of the study limb for spasticity within 6 months or with a dynamic
splint within 3 months, or planned casting or dynamic splinting for spasticity of the
study limb or affected upper limb during the study
We found this trial at
25
sites
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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