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

Primary Purpose

Stroke

Status

Recruiting

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

OnabotulinumtoxinA

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Spasticity, OnabotulinumtoxinA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Physical Medicine and Rehabilitation, National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

early OnabotulinumtoxinA group

late OnabotulinumtoxinA group

no OnabotulinumtoxinA group

Arm Description

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

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

OnabotulinumtoxinA will not be injected for this group.

Outcomes

Primary Outcome Measures

Modified Ashworth Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02580838

First Posted

October 11, 2015

Last Updated

September 29, 2022

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02580838

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Recruiting

Study Start Date

August 2015 (undefined)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Stroke, Spasticity, OnabotulinumtoxinA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

early OnabotulinumtoxinA group

Arm Type

Experimental

Arm Description

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

Arm Title

late OnabotulinumtoxinA group

Arm Type

Active Comparator

Arm Description

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

Arm Title

no OnabotulinumtoxinA group

Arm Type

No Intervention

Arm Description

OnabotulinumtoxinA will not be injected for this group.

Intervention Type

Drug

Intervention Name(s)

OnabotulinumtoxinA

Other Intervention Name(s)

Botox

Intervention Description

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.

Primary Outcome Measure Information:

Title

Modified Ashworth Scale

Time Frame

change from baseline Modified Ashworth Scale at 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Richard Lin

Phone

886-6-2353535

Ext

2666

richelin@mail.ncku.edu.tw

First Name & Middle Initial & Last Name or Official Title & Degree

Richard Lin

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Lin

Organizational Affiliation

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

138

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Lin

Phone

Tel: 886-6-2353535

Ext

2666

richelin@mail.ncku.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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

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