BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

Phase 2

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: onabotulinumtoxinA; Drug: Normal Saline

• Registration Number: NCT02230956
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-29
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Study Start: 2014-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2017-03-08
• Results First Submitted QC: 2017-03-08
• Results First Posted: 2017-04-20
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OnabotulinumtoxinA 200 U	onabotulinumtoxinA	OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
OnabotulinumtoxinA 400 U	onabotulinumtoxinA	OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
Placebo	Normal Saline	Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale	Baseline, Week 8	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale	Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24	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.
Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale	Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24	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.
Patient Global Impression of Change (GIC) Using a 7-Point Scale	Weeks 1, 4, 8, 12, 16, 20 and 24	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.
Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale	Baseline, Week 24	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.