BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

Allergan

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Normal Saline; Biological: onabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02230956

2014-001076-58 (EudraCT Number)

191622-145

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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176 participants in 3 patient groups, including a placebo group

OnabotulinumtoxinA 400 U

Experimental group

Description:

OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.

Treatment:

Biological: onabotulinumtoxinA

OnabotulinumtoxinA 200 U

Experimental group

Description:

OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.

Treatment:

Biological: onabotulinumtoxinA

Placebo

Placebo Comparator group

Description:

Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.

Treatment:

Drug: Normal Saline