NCT05289921

CompletedPhase 3

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

Huons Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

HU-014_P3_ULS

Study Type

interventional

Actual enrollment (reported)

198

Locations

1 country

Sites

1

Timeline

Study Start

March 4, 2022

Actual (reported)

Primary Completion

January 3, 2023

Actual (reported)

Study Completion

March 7, 2023

Actual (reported)

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

Registry Overview

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

Recruitment status: completed
Actual enrollment (reported): 198 participants
Study completion date: March 7, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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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
March 4, 2022
Actual (reported)
First Submitted
March 10, 2022
Actual (reported)
First Posted
March 22, 2022
Actual (reported)
Primary Completion
January 3, 2023
Actual (reported)
Study Completion
March 7, 2023
Actual (reported)

Last Updated: August 1, 2023
Status Verified: July 2023
Last Update Submitted: July 30, 2023

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 InjBiological

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

Clostridium botulinum type AHU-014 Inj

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

Eligibility Criteria

Age18 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, South Korea

Enrollment

198 participants (actual enrollment reported by the registry).

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

Actual (reported)

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.

Primary Completion

January 3, 2023

Actual (reported)

Study Completion

March 7, 2023

Actual (reported)

Last Updated

August 1, 2023

Record last verified: 2023-07

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: NCT05289921
Data provider: ClinicalTrials.gov
Source updated: 2023-08-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:38:09 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

HU-014 Inj

Clostridium botulinum type A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations