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MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity

Primary Purpose

Spasticity, Muscle

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Meditoxin
Sponsored by
Medy-Tox
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity, Muscle

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female over 20 years.
  2. Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.
  3. Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor.

Exclusion Criteria:

  1. Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
  2. Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.
  3. Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.
  4. Known immunization or hypersensitivity to any botulinum toxin preparations.
  5. Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Meditoxin®

    Arm Description

    Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size.

    Outcomes

    Primary Outcome Measures

    Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
    Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor in subjects with post stroke upper limb spasticity at week 4 after administration compared to baseline.

    Secondary Outcome Measures

    Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor
    Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of elbow flexor and finger flexor at week 4 and 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.
    Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
    Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor at week 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.
    The effective rate of wrist flexor, elbow flexor, and finger flexor
    The effective rate of wrist flexor, elbow flexor, and finger flexor at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit, defining the muscle with MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) score of ≥1 among the wrist flexor, elbow flexor, and finger flexor muscles as responders when the MAS is reduced by 1 score compared to baseline (week 0).
    Change in DAS (Disability Assessment Scale) score
    Change in score of goal assessment section in DAS (Disability Assessment Scale: Measures disability associated with upper limb spasticity in patients; score 0 to 3, 3 being the most severe disability) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
    Change in QOL (SF-36v2; Quality of Life) score
    Change in score of Short Form 36 ver.2 (SF-36v2; Quality of Life, QOL: a questionnaire with 36 questions regarding general health change affecting patient's quality of life; score from 1 up to 5, from minimum to high impact on quality of life) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
    Subject's or caregiver's global assessment
    Subject's or caregiver's global assessment (rating from -3 to +3 on the overall treatment effect, with +3 being very satisfied with treatment) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
    Number of participants with Adverse Events (AEs) to assess safety of investigational product.
    Safety of IP assessed by the number of partiicipants with adverse events determined by MedDra ver 16.0 from enrollment to the end of study.

    Full Information

    First Posted
    March 26, 2019
    Last Updated
    April 7, 2019
    Sponsor
    Medy-Tox
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03908580
    Brief Title
    MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity
    Official Title
    A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 6, 2013 (Actual)
    Primary Completion Date
    October 31, 2014 (Actual)
    Study Completion Date
    March 31, 2015 (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
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in 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
    Spasticity, Muscle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Meditoxin®
    Arm Type
    Experimental
    Arm Description
    Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size.
    Intervention Type
    Drug
    Intervention Name(s)
    Meditoxin
    Other Intervention Name(s)
    Neuronox®
    Intervention Description
    Meditoxin® (Botulinum toxin type A) was injected up to 360 U.
    Primary Outcome Measure Information:
    Title
    Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
    Description
    Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor in subjects with post stroke upper limb spasticity at week 4 after administration compared to baseline.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor
    Description
    Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of elbow flexor and finger flexor at week 4 and 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.
    Time Frame
    4 weeks, 16 weeks, and 4 weeks after re-visit
    Title
    Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
    Description
    Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor at week 16 after administration compared to baseline, and at 4 weeks after re-administration compared to the time of re-visit.
    Time Frame
    16 weeks, and 4 weeks after re-visit
    Title
    The effective rate of wrist flexor, elbow flexor, and finger flexor
    Description
    The effective rate of wrist flexor, elbow flexor, and finger flexor at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit, defining the muscle with MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) score of ≥1 among the wrist flexor, elbow flexor, and finger flexor muscles as responders when the MAS is reduced by 1 score compared to baseline (week 0).
    Time Frame
    4 weeks, 16 weeks, and 4 weeks after re-visit
    Title
    Change in DAS (Disability Assessment Scale) score
    Description
    Change in score of goal assessment section in DAS (Disability Assessment Scale: Measures disability associated with upper limb spasticity in patients; score 0 to 3, 3 being the most severe disability) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
    Time Frame
    4 weeks, 16 weeks, and 4 weeks after re-visit
    Title
    Change in QOL (SF-36v2; Quality of Life) score
    Description
    Change in score of Short Form 36 ver.2 (SF-36v2; Quality of Life, QOL: a questionnaire with 36 questions regarding general health change affecting patient's quality of life; score from 1 up to 5, from minimum to high impact on quality of life) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
    Time Frame
    4 weeks, 16 weeks, and 4 weeks after re-visit
    Title
    Subject's or caregiver's global assessment
    Description
    Subject's or caregiver's global assessment (rating from -3 to +3 on the overall treatment effect, with +3 being very satisfied with treatment) at week 4 and 16 compared to baseline and at week 4 after re-administration compared to re-visit.
    Time Frame
    4 weeks, 16 weeks, and 4 weeks after re-visit
    Title
    Number of participants with Adverse Events (AEs) to assess safety of investigational product.
    Description
    Safety of IP assessed by the number of partiicipants with adverse events determined by MedDra ver 16.0 from enrollment to the end of study.
    Time Frame
    Through study completion, an average of 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female over 20 years. Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial. Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor. Exclusion Criteria: Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.). Subjects with fixed joint, muscle contracture, or atrophy in the treatment area. Subjects with botulinum toxin treatment within 3 months before administration of the investigational product. Known immunization or hypersensitivity to any botulinum toxin preparations. Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics

    12. IPD Sharing Statement

    Learn more about this trial

    MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity

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