BOTOX® Treatment in Pediatric Lower Limb Spasticity

Study Identifier
191622-111
CT.gov Identifier
NCT01603628
EudraCT Identifier
2012-000042-35
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Study Details

Medical Condition
  • Pediatrics
  • Movement Disorders - Other
    • Study Drug
  • botulinum toxin Type A
  • Normal Saline (Placebo)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    2 - 16 Years
    Inclusion and Exclusion Criteria
    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

    Protocol Summary

    This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

    Study Locations

    Location
    Status
    Location
    AMS Neurology
    Pasadena, California, United States, 91106
    Status
    Not applicable
    Location
    Harrison Clinical Management
    Pomona, California, United States, 91767
    Status
    Not applicable
    Location
    Children's Hospital Colorado Dept. of PM&R
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Associated Neurologists of Southern CT, P.C.
    Fairfield, Connecticut, United States, 06824
    Status
    Not applicable
    Location
    New England Center for Clinical Research
    Stamford, Connecticut, United States, 06905
    Status
    Not applicable
    Location
    NW FL Clinical Research Group, LLC
    Gulf Breeze, Florida, United States, 32561
    Status
    Not applicable
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