Phase 2
Completed N=176
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Source: ClinicalTrials.gov NCT02230956 ↗Enrolled (actual)
176
Serious AEs
9.1%
Results posted
Apr 2017
Primary outcomePrimary: Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale — 5.92; 6.09; 6.00; -1.68 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale |
5.92; 6.09; 6.00; -1.68; -2.07; -1.98 | — |
| SECONDARY Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale |
5.84; 5.41; 5.34; -1.75; -1.61; -1.62 | — |
| SECONDARY Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale |
5.56; 5.35; 4.99; -1.33; -1.64; -1.44 | — |
| SECONDARY Patient Global Impression of Change (GIC) Using a 7-Point Scale |
0.9; 1.2; 1.1; 0.9; 1.2; 1.2 | — |
| SECONDARY Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale |
6.50; 6.84; 6.63; -1.48; -2.07; -1.80 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02230956). 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.