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

National Cheng-Kung University

Status and phase: Enrolling; Phase 3

Conditions: Stroke

Treatments: Drug: OnabotulinumtoxinA

Study type: Interventional

Funder types: Other

Identifiers

NCT02580838

B-BR-102-032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

early OnabotulinumtoxinA group

Experimental group

Description:

OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group.

Treatment:

Drug: OnabotulinumtoxinA

late OnabotulinumtoxinA group

Active Comparator group

Description:

OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group.

Treatment:

Drug: OnabotulinumtoxinA

no OnabotulinumtoxinA group

No Intervention group

Description:

OnabotulinumtoxinA will not be injected for this group.