NCT00076687

Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke spasticity

Conditions

• Stroke
• Muscle Spasticity
• Motor Neuron Disease

Interventions

Type	Name	Description
BIOLOGICAL	botulinum toxin Type A	botulinum toxin Type A 240 U injection on Day 1, Week 12, Week 18
BIOLOGICAL	botulinum toxin Type A	botulinum toxin Type A 360 U injection at Day 1, Week 12, Week 18
DRUG	saline	Saline injection at Day 1, Week 12, Week 18

Timeline

• Start date: 2003-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2004-02-26
• Last updated: 2011-10-03
• Results posted: 2011-10-03

Locations

4 sites across 4 countries: United States, Czechia, Hungary, Poland