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
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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