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

Allergan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteoarthritis

Treatments: Drug: Normal Saline; Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01518257

191622-102

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups, including a placebo group

botulinum toxin Type A

Experimental group

Description:

A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.

Treatment:

Biological: botulinum toxin Type A

Placebo

Placebo Comparator group

Description:

A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Treatment:

Drug: Normal Saline