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
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    13
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
Study Started
Nov 06
2019
Primary Completion
Jun 30
2020
Anticipated
Study Completion
Oct 31
2020
Anticipated
Last Update
Jun 04
2020

Biological HU-014 Inj

Clostridium botulinum type A

HU-014 Inj(Phase 1 Experimental

HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)

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.
No Results Posted