BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

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.

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