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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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