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Completed

NCT Number: NCT05289921

To Evaluate HU-014 in the Treatment of Post Stroke Upper Limb

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HU-014 Inj

Biological

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

Primary outcomes

  1. MAS score improvement at Wrist Flexor

    Time frame: 4 weeks

    The rate of change in muscle tension measured by MAS

Sponsors and collaborators

Lead sponsor

Huons Co., Ltd.

Industry

Registry information

Official study title

Multi Center, Phase III Clinical Trial to Evaluate the Safety and Efficacy of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

Acronym: HU-014

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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