NCT02580838

The Effects of Early and Late Injection of Botulinum Toxin Type A on Upper Limb Function in Patients With Stroke

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine whether early use of OnabotulinumtoxinA is more effective to improve functional outcomes of upper limb in patients with stroke.

Detailed description

Many patients surviving stroke have significant impairment of function in the affected upper limb due to the development of spasticity. Botulinum toxin type A injection is a powerful treatment option for control of spasticity. In this study, the patients will be randomly assigned into three groups: early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention. The aim of this randomized controlled study is to evaluate the effects of early and late injection of botulinum toxin type A on upper limb function in patients with stroke.

Conditions

• Stroke

Interventions

Type	Name	Description
DRUG	OnabotulinumtoxinA	Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.

Timeline

• Start date: 2015-08-01
• Primary completion: 2023-09-01
• Completion: 2025-09-01
• First posted: 2015-10-20
• Last updated: 2022-09-30

Locations

1 site across 1 country: Taiwan