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

NCT05289921 | Completed Phase 3

• 1 other identifier: HU-014_P3_ULS
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Post Stroke Upper Limb Spasticity

Outcome Measures

Primary Outcomes (1)

• MAS score improvement at Wrist Flexor

  The rate of change in muscle tension measured by MAS

  4 weeks

Study Arms (2)

HU-014 Inj

EXPERIMENTAL

HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)

Biological: HU-014 Inj

Clostridium botulinum type A

ACTIVE COMPARATOR

Clostridium botulinum type A Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)

Biological: HU-014 Inj

Interventions

HU-014 Inj BIOLOGICAL

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

Clostridium botulinum type A; HU-014 Inj

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huons Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 22, 2022
• Study Start: March 4, 2022
• Primary Completion: January 3, 2023
• Study Completion: March 7, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

KR (1)