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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Spasticity, Muscle

Intervention / Treatment
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* Drug: Meditoxin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditoxin®<br>Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size. | Drug: Meditoxin<br>* Meditoxin® (Botulinum toxin type A) was injected up to 360 U.<br>* Other names: Neuronox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks, 16 weeks, and 4 weeks after 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. | 16 weeks, and 4 weeks after 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). | 4 weeks, 16 weeks, and 4 weeks after re-visit | 
| 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. | 4 weeks, 16 weeks, and 4 weeks after 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. | 4 weeks, 16 weeks, and 4 weeks after 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. | 4 weeks, 16 weeks, and 4 weeks after 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. | Through study completion, an average of 1 year |