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

Last updated: July 30, 2023
Sponsor: Huons Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Stroke

Limb Spasticity

Cerebral Ischemia

Treatment

HU-014 Inj

Clinical Study ID

NCT05289921
HU-014_P3_ULS
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 andFlexor or Finger Flexor is ≥ 1.
  • A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of thecategories of hand hygiene, clothing, upper extremity, or pain for evaluation.

Exclusion

Exclusion Criteria:

  • A subject who has medical history following. (Allergy, Chemodenervation(within 6months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspirationpneumonia, etc.)
  • A subject who has history of any diseases following. (neuromuscular junction disorder,NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateralsclerosis, ALS, Skin disease, Dysphagia, etc.)
  • From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesisimplantation 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 isscheduled to be administered.
  • A sugject who has muscle atrophy, fixed joint/muscle contracture in the area wheremedication for clinical trials is scheduled to be administered.
  • Any condition that, in the view of the investigator, would interfere with studyparticipation.

Study Design

Total Participants: 198
Treatment Group(s): 1
Primary Treatment: HU-014 Inj
Phase: 3
Study Start date:
March 04, 2022
Estimated Completion Date:
March 07, 2023

Connect with a study center

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.