NCT04415346

UnknownPhase 1

A Single Center, Phase I Clinical Trial to Evaluate the Safe...

Huons Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

HU-014_P1_ULS

Study Type

interventional

Actual enrollment (reported)

13

Locations

1 country

Sites

1

Timeline

Study Start

November 6, 2019

Actual (reported)

Primary Completion

June 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Actual enrollment (reported): 13 participants
Study completion date: October 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 6, 2019
Actual (reported)
First Submitted
May 31, 2020
Actual (reported)
Primary Completion
June 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Posted
June 4, 2020
Actual (reported)
Study Completion
October 2020
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: June 4, 2020
Status Verified: May 2020
Last Update Submitted: May 31, 2020

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 InjBiological

Clostridium botulinum type A

HU-014 Inj(Phase 1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Huons Co., Ltd.
Industrylead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Study Officials

Min-ho Chun, M.D.,Ph.D.
Department of Physical Medicine&Rehabilitation
PRINCIPAL INVESTIGATOR

Enrollment

13 participants (actual enrollment reported by the registry).

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

Actual (reported)

Primary Completion

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.

Contact the study team to confirm eligibility.

June 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

October 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

June 4, 2020

Record last verified: 2020-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04415346
Data provider: ClinicalTrials.gov
Source updated: 2020-06-04
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:19 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

HU-014 Inj(Phase 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations