BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

Study Identifier
191622-116
CT.gov Identifier
NCT01575054
EudraCT Identifier
2011-004980-63
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Movement Disorders - Other
    • Study Drug
  • botulinum toxin Type A
  • Normal Saline
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 85 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of post-stroke lower limb spasticity for at least 3 months * Minimum body weight of 50 kg * Never treated with botulinum toxin of any serotype for any reason, or if previously treated with botulinum toxin of any serotype, if previously treated for spasticity in the affected lower limb, must have been administered * 20 weeks before Day 1, or if previously treated for any other indication must have been administered ≥12 weeks prior to Day 1
    Exclusion Criteria:
    * Spasticity in the opposite leg that requires treatment * Casting of the study limb within 6 months or planned casting during the first 12 weeks of the study * Treatment modalities in the study limb including ultrasound, electrical nerve stimulation, electrical stimulation, acupuncture within 1 month of Day 1 or treatments planned during the study * Not able to perform 10 meter walking test independently with or without assistive device * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

    Protocol Summary

    This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.

    Study Locations

    Location
    Status
    Location
    Downey, California, United States
    Status
    Not applicable
    Location
    Daytona Beach, Florida, United States
    Status
    Not applicable
    Location
    Montreal, Quebec, Canada
    Status
    Not applicable
    Location
    Prague, Czech Republic
    Status
    Not applicable
    Location
    Wiesbaden, Germany
    Status
    Not applicable
    Location
    Würzburg, Germany
    Status
    Not applicable
    Showing {first} - {last} of {total} Results