BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: 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

• 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