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 1Lead Sponsor
Huons Co.,Ltd.Study Type
InterventionalStatus
Unknown statusIndication/Condition
Post Stroke Upper Limb SpasticityIntervention/Treatment
HU-014 InjStudy Participants
13Investigational 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
Clostridium botulinum type A
HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)
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.