Post Stroke Upper Limb SpasticityPhase 1NCT04415346
A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
A Phase 1 study testing HU-014 Inj in people with Post Stroke Upper Limb Spasticity, run by Huons Co., Ltd. at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post Stroke Upper Limb Spasticity
- What is being tested?
- HU-014 Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2019to Oct 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
- 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
- Being tested
- HU-014 Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU-014 InjBiological
Clostridium botulinum type A
| Study group | Role | What they receive |
|---|---|---|
| HU-014 Inj(Phase 1 | Experimental | HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM) Receives: Biological: HU-014 Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor
The rate of change in muscle tension measured by MAS
Measured: Week 4, 8, 12 from baseline visit(=Investigational product Injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start6 Nov 2019
- Primary completionJun 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke Upper Limb SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-ho Chun, M.D.,Ph.D., Principal investigator, Department of Physical Medicine&Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415346
- Sponsor's protocol ID
- HU-014_P1_ULS
- Status last verified
- May 2020
- First submitted
- 31 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
- ClinicalTrials.gov ID
- NCT04415346
- Acronym / sponsor ID
- HU-014_P1_ULS
- Conditions
- Post Stroke Upper Limb Spasticity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HU-014 Inj(Phase 1 | Experimental | Biological: HU-014 InjHU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HU-014 InjClostridium botulinum type A | Biological | HU-014 Inj(Phase 1 |
Primary outcome
MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor
Time frame: Week 4, 8, 12 from baseline visit(=Investigational product Injection)
The rate of change in muscle tension measured by MAS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Related trials for Post Stroke Upper Limb Spasticity
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ESTIM-UL: FES for Upper Limb Recovery After Stroke
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Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-ho Chun, M.D.,Ph.D. principal investigator
Department of Physical Medicine&Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HU-014 Inj in people with Post Stroke Upper Limb Spasticity, run by Huons Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor (time frame: Week 4, 8, 12 from baseline visit(=Investigational product Injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.