BOTOX® Treatment in Pediatric Upper Limb Spasticity

Study Identifier
191622-101
CT.gov Identifier
NCT01603602
EudraCT Identifier
2012-000062-38
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
  • Stroke
    • 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 * Upper limb spasticity due to cerebral palsy or stroke
    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 * Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study 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 lower limb during the study

    Protocol Summary

    This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper 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, 91766
    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
    NW FL Clinical Research Group, LLC
    Gulf Breeze, Florida, United States, 32561
    Status
    Not applicable
    Location
    Axcess Medical Research, LLC
    Loxahatchee Groves, Florida, United States, 33470
    Status
    Not applicable
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