BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

Allergan176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

176

Conditions

Osteoarthritis

Interventions

onabotulinumtoxinABIOLOGICAL

onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.

Normal SalineDRUG

Normal Saline (placebo) injection into the intra-articular space of the study knee.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Artesia, California, United States

Unnamed facility

Pardubice, Czechia

Unnamed facility

Vejle, Denmark

Outcomes

Primary Outcomes

Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale

Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.

Time frame: Baseline, Week 8

Secondary Outcomes

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale

The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24

Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale

The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.

Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24

Patient Global Impression of Change (GIC) Using a 7-Point Scale

The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.

Time frame: Weeks 1, 4, 8, 12, 16, 20 and 24

Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale

Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.

Data from ClinicalTrials.gov

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