Phase 2
Completed N=121
Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
Source: ClinicalTrials.gov NCT01518257 ↗Enrolled (actual)
121
Serious AEs
0.8%
Results posted
Aug 2014
Primary outcomePrimary: Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4 — 6.4; 6.5; -1.8; -1.8 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4 |
6.4; 6.5; -1.8; -1.8 | — |
| PRIMARY Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8 |
6.4; 6.5; -2.2; -2.3 | — |
| PRIMARY Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12 |
6.4; 6.5; -2.2; -2.5 | — |
| SECONDARY Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score |
104.5; 107.6; -46.5; -43.8 | — |
| SECONDARY Change From Baseline in WOMAC Pain Score |
23.9; 24.3; -10.7; -11.0 | — |
| SECONDARY Change From Baseline in WOMAC Physical Function Score |
71.0; 73.3; -31.7; -28.6 | — |
| SECONDARY Patient Global Impression of Change Score |
1.3; 1.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01518257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.