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

Phase 3

Completed

• Conditions: Post Stroke Upper Limb Spasticity
• Interventions: Biological: HU-014 Inj

• Registration Number: NCT05289921
• Lead Sponsor: Huons Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-04
• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-22
• Primary Completion: 2023-01-03
• Study Completion: 2023-03-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HU-014 Inj	HU-014 Inj	HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)
Clostridium botulinum type A	HU-014 Inj	Clostridium botulinum type A Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)

Primary Outcome Measures

Name	Time	Method
MAS score improvement at Wrist Flexor	4 weeks	The rate of change in muscle tension measured by MAS

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of