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Clinical trial

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

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Last updated:1st Apr 2012

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

Category Value
Study start date 2012-04-01

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