Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 121
- Primary Endpoint
- Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
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.
Intervention: botulinum toxin Type A (Biological)
Placebo
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score(Baseline, Week 8)
- Change From Baseline in WOMAC Pain Score(Baseline, Week 8)
- Change From Baseline in WOMAC Physical Function Score(Baseline, Week 8)
- Patient Global Impression of Change Score(Week 8)