Back to resultsA Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
Primary Purpose
Post Stroke Upper Limb Spasticity
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HU-014 Inj
Sponsored by
About this trial
This is an interventional treatment trial for Post Stroke Upper Limb Spasticity
Eligibility Criteria
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.
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HU-014 Inj(Phase 1
Arm Description
HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)
Outcomes
Primary Outcome Measures
MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor
The rate of change in muscle tension measured by MAS
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04415346
Brief Title
A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
Official Title
A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huons Co., Ltd.
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Stroke Upper Limb Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HU-014 Inj(Phase 1
Arm Type
Experimental
Arm Description
HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)
Intervention Type
Biological
Intervention Name(s)
HU-014 Inj
Intervention Description
Clostridium botulinum type A
Primary Outcome Measure Information:
Title
MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor
Description
The rate of change in muscle tension measured by MAS
Time Frame
Week 4, 8, 12 from baseline visit(=Investigational product Injection)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min-ho Chun, M.D.,Ph.D.
Organizational Affiliation
Department of Physical Medicine&Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
05505
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
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