CompletedInterventionalPhase 2Updated May 21, 2018
Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain | NCT01518257 | Trialant
CompletedInterventionalPhase 1Phase 2Updated Aug 7, 2014
Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
ClinicalTrials.gov ID
NCT01518257
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1Phase 2
Enrollment
121Actual
Last Update Posted
Aug 7, 2014Estimated
Start Date
Jan 2012
Primary Completion Date
Jan 2013Actual
Completion Date
Jan 2013Actual
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.
Osteoarthritis
botulinum toxin Type A
Normal Saline
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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