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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: botulinum toxin Type A; Drug: Normal Saline

• Registration Number: NCT01518257
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-25
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Disposition First Submitted: 2014-01-27
• Disposition First Submitted QC: 2014-01-27
• Disposition First Posted: 2014-02-27
• Status Verified: 2014-07
• Results First Submitted: 2014-07-15
• Results First Submitted QC: 2014-07-15
• Last Update Submitted: 2014-07-15
• Results First Posted: 2014-08-07
• Last Update Posted: 2014-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
botulinum toxin Type A	botulinum toxin Type A	A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
Placebo	Normal Saline	A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4	Baseline, Week 4	The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8	Baseline, Week 8	The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12	Baseline, Week 12	The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score	Baseline, Week 8	The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.
Change From Baseline in WOMAC Pain Score	Baseline, Week 8	The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.
Change From Baseline in WOMAC Physical Function Score	Baseline, Week 8	The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.
Patient Global Impression of Change Score	Week 8	The participants 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 indicated worsening and positive scores indicated improvement.