Conditions: Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 176
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. arm 2: OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. arm 3: Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.

Interventions: intervention 1: onabotulinumtoxinA intervention 2: Normal Saline
Intervention descriptions: intervention 1: onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee. intervention 2: Normal Saline (placebo) injection into the intra-articular space of the study knee.

Protocol document: