BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

Study Identifier
191622-112
CT.gov Identifier
NCT01603641
EudraCT Identifier
2012-000084-24
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

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

Medical Condition
  • Pediatrics
  • Movement Disorders - Other
    • Study Drug
  • Botulinum Toxin Type A
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    2 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Minimum weight of 10 kilograms (kg)/22 pounds (lb) * Cerebral palsy with dynamic muscle contracture 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 3 months * History of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study

    Protocol Summary

    This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.

    Study Locations

    Location
    Status
    Location
    ABS Health, LLC
    Pasadena, California, United States, 91106
    Status
    Not applicable
    Location
    Harrison Clinical Management
    Pomona, California, United States, 91767
    Status
    Not applicable
    Location
    Rady Children's Hospital San Diego
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Children's Hospital Colorado
    Aurora, Colorado, United States, 80045
    Status
    Not applicable
    Location
    Associated Neurologists of Southern Connecticut, P.C.
    Fairfield, Connecticut, United States, 06824
    Status
    Not applicable
    Location
    New England Institute for Clinical Research
    Stamford, Connecticut, United States, 06905
    Status
    Not applicable
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