NCT01575054

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Muscle Spasticity

Interventions

Type	Name	Description
BIOLOGICAL	botulinum toxin Type A	Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
DRUG	Normal Saline	Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-09-01
• Completion: 2015-07-01
• First posted: 2012-04-11
• Last updated: 2016-09-28
• Results posted: 2016-02-01

Locations

12 sites across 9 countries: United States, Canada, Czechia, Germany, Hungary, Poland, Russia, South Korea, United Kingdom