Status:
COMPLETED
Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
Lead Sponsor:
Allergan
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01518257
Start Date
January 1 2012
End Date
January 1 2013
Last Update
August 7 2014
Active Locations (1)
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1
Aalborg, Denmark