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

September 29, 2022 updated by: National Cheng-Kung University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Richard Lin

Study Locations

  • Taiwan
      • Tainan, Taiwan, 138
        • Recruiting
        • Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: early OnabotulinumtoxinA group
OnabotulinumtoxinA will be injected immediately when spasticity develop in early OnabotulinumtoxinA group.
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.
Other Names:
  • Botox
ACTIVE_COMPARATOR: late OnabotulinumtoxinA group
OnabotulinumtoxinA will be injected at 6 months after emergence of spasticity in late OnabotulinumtoxinA group.
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.
Other Names:
  • Botox
NO_INTERVENTION: no OnabotulinumtoxinA group
OnabotulinumtoxinA will not be injected for this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Ashworth Scale
Time Frame: change from baseline Modified Ashworth Scale at 4 weeks
change from baseline Modified Ashworth Scale at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: Richard Lin, Department of physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

September 1, 2023

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

October 11, 2015

First Submitted That Met QC Criteria

October 18, 2015

First Posted (ESTIMATE)

October 20, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-BR-102-032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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