OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity

Study Identifier
191622-127
CT.gov Identifier
NCT02145676
EudraCT Identifier
2013-002346-37
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Movement Disorders - Other
  • Stroke
    • Study Drug
  • onabotulinumtoxinA
  • placebo (normal saline)
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 80 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago
    Exclusion Criteria:
    * Spasticity in the non-study upper limb that requires treatment * Presence of fixed contractures in of the study muscles in elbow or shoulder * Profound atrophy of muscles to be injected * Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months * Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months * Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month * Condition other than stroke contributing to upper limb spasticity * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis

    Protocol Summary

    This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with upper limb spasticity.

    Study Locations

    Location
    Status
    Location
    Overland Park, Kansas, United States
    Status
    Not applicable
    Location
    Montreal, Quebec, Canada
    Status
    Not applicable