Status:
COMPLETED
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Lead Sponsor:
Allergan
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Painful osteoarthritis
- Able to discontinue anti-inflammatory drugs and analgesics
- Must be ambulatory without assistive walking devices
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT02230956
Start Date
October 1 2014
End Date
March 1 2016
Last Update
May 31 2017
Active Locations (3)
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1
Artesia, California, United States
2
Pardubice, Czechia
3
Vejle, Denmark