BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

Study Identifier
191622-145
CT.gov Identifier
NCT02230956
EudraCT Identifier
2014-001076-58
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Osteoarthritis
    • Study Drug
  • onabotulinumtoxinA
  • Normal Saline
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    40 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Painful osteoarthritis * Able to discontinue anti-inflammatory drugs and analgesics * Must be ambulatory without assistive walking devices
    Exclusion Criteria:
    * Chronic pain conditions other than knee osteoarthritis * Treatment with corticosteroids in the study knee within 12 weeks * Treatment with hyaluronic acid in the study knee within 24 weeks * Previous treatment with any botulinum toxin for any reason * Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

    Protocol Summary

    This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.

    Study Locations

    Location
    Status
    Location
    Artesia, California, United States
    Status
    Not applicable
    Location
    Pardubice, Czech Republic
    Status
    Not applicable
    Location
    Vejle, Denmark
    Status
    Not applicable