A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

NCT04415346 | Unknown Phase 1

• 1 other identifier: HU-014_P1_ULS
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

• Investigational Product: LIZTOX inj 100unit(HU-014)
• Title : A Single Center, Phase I Clinical Trial to Evaluate the 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 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, Elbow Flexor, Finger Flexor

  The rate of change in muscle tension measured by MAS

  Week 4, 8, 12 from baseline visit(=Investigational product Injection)

Study Arms (1)

HU-014 Inj(Phase 1

EXPERIMENTAL

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

Biological: HU-014 Inj

Interventions

HU-014 Inj BIOLOGICAL

Clostridium botulinum type A

HU-014 Inj(Phase 1

Eligibility Criteria

• Age: 19 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, Songpa-gu, 05505, South Korea

Location

Study Officials

• Min-ho Chun, M.D.,Ph.D.

  Department of Physical Medicine&Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 4, 2020
• Study Start: November 6, 2019
• Primary Completion: June 1, 2020
• Study Completion: October 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-05

Locations

KR (1)