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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02580838
• Other study ID #: B-BR-102-032
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2015
• Est. completion date: September 2025

Study information

• Verified date: October 2015
• Source: National Cheng-Kung University Hospital
• Contact: Richard Lin
• Phone: 886-6-2353535
• Email: richelin[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2025
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• stroke affecting one body side

• spasticity develops after stroke

Exclusion Criteria:

• musculoskeletal conditions that affected upper limb function prior to stroke

• concurrent use of anti-spasticity medications

• patients with neuromuscular junction or myopathic disorders such as myasthenia gravis or others

• patients with a known allergy to any onabotulinumtoxinA or to any of the excipients of onabotulinumtoxinA (such as human serum albumin)

• patients who are pregnant or may become pregnant at the time of the proposed injection

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Ashworth Scale		change from baseline Modified Ashworth Scale at 4 weeks