Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

March 27, 2019 updated by: Medy-Tox

Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity

Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subject aged over 20.
  2. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
  3. Subjects who was diagnosed stroke at least 1 month prior to study participation.
  4. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.

Exclusion Criteria:

  1. Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
  2. Subjects with allergy or hypersensitivity to the Botulinum Toxin.
  3. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
  4. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
  5. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
  6. Subjects who have been injected with botulinum toxin within past 3 months before the injection.
  7. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
  8. Subjects who are scheduled to take part in other clinical trial during the study period.
  9. Patients who are not eligible for this study at the medical discretion of the investigator.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonography guidance
Ultrasonography guidance injection of Meditoxin®.
Drug: Ultrasonography guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.
Experimental: Electrical stimulation guidance
Electrical stimulation guidance injection of Meditoxin®.
Drug: Electrical stimulation guidance injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.
Experimental: Manual needle placement
Manual needle placement injection of Meditoxin®.
Drug: Manual needle placement injection of Meditoxin®.
Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.
Time Frame: 4 weeks
4 weeks
Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Medy-Tox

Investigators

  • Principal Investigator: MyungEun Chung, St. Paul's Hospital, The Catholic University of Korea

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 (Actual)

May 30, 2016

Primary Completion (Actual)

August 16, 2016

Study Completion (Actual)

August 16, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT_PRT_ST04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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