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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05289921
Other study ID # HU-014_P3_ULS
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 4, 2022
Est. completion date March 7, 2023

Study information

Verified date July 2023
Source Huons Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigational Product: LIZTOX inj 100unit(HU-014) Title : Multi Center, Phase III Clinical Trial to Evaluate the efficacy and 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 efficacy and safety of LIZTOX inj in the treatment of Post Stroke Upper Limb Spasticity


Recruitment information / eligibility

Status Completed
Enrollment 198
Est. completion date March 7, 2023
Est. primary completion date January 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
HU-014 Inj
HU-014 Inj was given an injection to 5 Upper limb muscle

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Huons Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary MAS score improvement at Wrist Flexor The rate of change in muscle tension measured by MAS 4 weeks
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04415346 - A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity Phase 1