BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity

This study will evaluate the safety and efficacy of BOTOX^® in the treatment of adult post-stroke lower limb spasticity.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Enrollment: 468
Study Start Date: April 2012
Estimated Study Completion Date: July 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: botulinum toxin Type A
- Normal Saline (Placebo) Followed by botulinum toxin Type A