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

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

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

Study Overview

• Status: Completed
• Conditions: Post Stroke Upper Limb Spasticity
• Intervention / Treatment: Biological: HU-014 Inj

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HU-014 Inj; HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)	Biological: HU-014 Inj; HU-014 Inj was given an injection to 5 Upper limb muscle
Active Comparator: Clostridium botulinum type A; Clostridium botulinum type A Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)	Biological: HU-014 Inj; HU-014 Inj was given an injection to 5 Upper limb muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAS score improvement at Wrist Flexor	The rate of change in muscle tension measured by MAS	4 weeks

Collaborators and Investigators

• Sponsor: Huons Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): March 7, 2023

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 30, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity
• Other Study ID Numbers: HU-014_P3_ULS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No