At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 176 enrolled
Drug / intervention
onabotulinumtoxinA +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
In Brief
A Phase 2 clinical trial evaluating onabotulinumtoxinA and Normal Saline for Osteoarthritis. Completed, enrolled 176 participants across 3 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesCzechia, Denmark, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartOct 2014
Primary CompletionMar 2016
TodayJul 2026
First PostedSep 3, 2014
Enrollment StartOct 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.8 years ago
Interventions
onabotulinumtoxinAbiological
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
Normal Salinedrug
Normal Saline (placebo) injection into the intra-articular space of the study knee.