BOTOX® Economic Spasticity Trial (BEST)

Study Identifier
AGN/HO/SPA/001-191622
CT.gov Identifier
NCT00549783
EudraCT Identifier
Not available
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 900kD
  • Placebo
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    18 - 85 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Patients with stroke due to a primary cerebral hemorrhage/infarction * Subarachnoid hemorrhage producing an upper motor syndrome affecting one body side which results in a hemi-paralysis/plegia
    Exclusion Criteria:
    * Patients with fixed contracture as a result of spasticity in the upper or lower limb planned to be treated and/or patients with other causes of spasticity (e.g. multiple sclerosis, spinal cord injury, etc.)

    Protocol Summary

    This is a study to investigate if patients who have had a stroke and suffer from spasticity might benefit from being given BOTOX® in addition to the normal Standard Care. Spasticity is characterized by stiffness or frequent cramps accompanied by pain and abnormal movements and can prevent the carrying out of everyday tasks such as walking and getting dressed. BOTOX® is a neurotoxin, which is used to prevent the contraction of muscle fibre and has been shown to reduce spasticity significantly. Patients will be enrolled in this study at about 33 locations in Europe and Canada. Study participation will last for about 1 year.

    Study Locations

    Location
    Status
    Location
    Edmonton, Alberta, Canada
    Status
    Not applicable
    Location
    Beelitz, Germany
    Status
    Not applicable
    Location
    Uppsala, Sweden
    Status
    Not applicable
    Location
    Burslem, Stoke-on-Trent, United Kingdom
    Status
    Not applicable