A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

Study Overview
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Brief Summary
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Investigational Product: LIZTOX inj 100unit(HU-014) Title : A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D Objective : To evaluate the safety of LIZTOX inj in the treatment of Post Stroke Upper Limb Spasticity

Official Title
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A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

Conditions
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Post Stroke Upper Limb Spasticity

Intervention / Treatment
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* Biological: HU-014 Inj


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject who is diagnosed with Stroke at least six weeks prior to Screening. A subject who has Modified ashworth scale(MAS) score which Wrist Flexor is ≥ 2 and Flexor or Finger Flexor is ≥ 1. A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of the categories of hand hygiene, clothing, upper extremity, or pain for evaluation. Exclusion Criteria: A subject who has medical history following. (Allergy, Chemodenervation(within 6 months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspiration pneumonia, etc.) A subject who has history of any diseases following. (neuromuscular junction disorder, NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, ALS, Skin disease, Dysphagia, etc.) From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc. A subject who tend to bleed or are taking anti-coagulant drugs. A sugject who is undergoing rehabilitation(physical therapy, occupational therapy, exercise therapy) or Splinting in the area where medication for clinical trials is scheduled to be administered. A sugject who has muscle atrophy, fixed joint/muscle contracture in the area where medication for clinical trials is scheduled to be administered. Any condition that, in the view of the investigator, would interfere with study participation.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

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: HU-014 Inj(Phase 1<br>HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM) | Biological: HU-014 Inj<br>* Clostridium botulinum type A<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor | The rate of change in muscle tension measured by MAS | Week 4, 8, 12 from baseline visit(=Investigational product Injection) |