BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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OnabotulinumtoxinA 400 U

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

Group Type EXPERIMENTAL

onabotulinumtoxinA

Intervention Type BIOLOGICAL

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

OnabotulinumtoxinA 200 U

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

Group Type EXPERIMENTAL

onabotulinumtoxinA

Intervention Type BIOLOGICAL

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

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

Interventions

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onabotulinumtoxinA

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

Intervention Type BIOLOGICAL

Normal Saline

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

Intervention Type DRUG

Other Intervention Names

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botulinum toxin Type A BOTOX®

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No