Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain

Study Identifier
191622-102
CT.gov Identifier
NCT01518257
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
  • Osteoarthritis
    • Study Drug
  • botulinum toxin Type A
  • Normal Saline
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    40 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Painful osteoarthritis in the study knee * Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study
    Exclusion Criteria:
    * Chronic pain conditions other than knee osteoarthritis * Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year * Surgery to the study knee within 24 weeks * Treatment with hyaluronic acid in the study knee within 24 weeks * Treatment with corticosteroids in the study knee within 12 weeks * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis * Previous treatment with botulinum toxin of any serotype for any reason

    Protocol Summary

    This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.

    Study Locations

    Location
    Status
    Location
    Aalborg, Denmark
    Status
    Not applicable