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Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

Primary Purpose

Muscle Spasticity

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Ultrasonography guidance injection of Meditoxin®.

Electrical stimulation guidance injection of Meditoxin®.

Manual needle placement injection of Meditoxin®.

About this trial

This is an interventional treatment trial for Muscle Spasticity focused on measuring botulinum toxin, spasticity, injection technique, neuronox, meditoxin

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Ultrasonography guidance

Electrical stimulation guidance

Manual needle placement

Arm Description

Ultrasonography guidance injection of Meditoxin®.

Electrical stimulation guidance injection of Meditoxin®.

Manual needle placement injection of Meditoxin®.

Outcomes

Primary Outcome Measures

Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.

Secondary Outcome Measures

Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.

Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.

Full Information

NCT ID

NCT02757404

First Posted

April 25, 2016

Last Updated

March 27, 2019

Sponsor

Medy-Tox

1. Study Identification

Unique Protocol Identification Number

NCT02757404

Brief Title

Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

May 30, 2016 (Actual)

Primary Completion Date

August 16, 2016 (Actual)

Study Completion Date

August 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medy-Tox

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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".

6. Conditions and Keywords

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

Muscle Spasticity

Keywords

botulinum toxin, spasticity, injection technique, neuronox, meditoxin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasonography guidance

Arm Type

Experimental

Arm Description

Ultrasonography guidance injection of Meditoxin®.

Arm Title

Electrical stimulation guidance

Arm Type

Experimental

Arm Description

Electrical stimulation guidance injection of Meditoxin®.

Arm Title

Manual needle placement

Arm Type

Experimental

Arm Description

Manual needle placement injection of Meditoxin®.

Intervention Type

Drug

Intervention Name(s)

Ultrasonography guidance injection of Meditoxin®.

Intervention Description

Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.

Intervention Type

Drug

Intervention Name(s)

Electrical stimulation guidance injection of Meditoxin®.

Intervention Description

Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.

Intervention Type

Drug

Intervention Name(s)

Manual needle placement injection of Meditoxin®.

Intervention Description

Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.

Primary Outcome Measure Information:

Title

Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.

Time Frame

4 weeks

Title

Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subject aged over 20. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke. Subjects who was diagnosed stroke at least 1 month prior to study participation. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent. Exclusion Criteria: Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment. Subjects with allergy or hypersensitivity to the Botulinum Toxin. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis). Subjects who have been injected with botulinum toxin within past 3 months before the injection. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period. Subjects who are scheduled to take part in other clinical trial during the study period. Patients who are not eligible for this study at the medical discretion of the investigator.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MyungEun Chung

Organizational Affiliation

St. Paul's Hospital, The Catholic University of Korea

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

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