Post Stroke Upper Limb SpasticityPhase 3HU-014NCT05289921
To Evaluate HU-014 in the Treatment of Post Stroke Upper Limb
A Phase 3 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 : 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… Read more about this study
- Who is it for?
- Ages 18 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
- 198 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Mar 2022to 7 Mar 2023
- Phase
- Phase 3
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 18 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
Official title: Multi Center, Phase III Clinical Trial to Evaluate the Safety and Efficacy of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
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
- 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
HU-014 Inj was given an injection to 5 Upper limb muscle
| Study group | Role | What they receive |
|---|---|---|
| HU-014 Inj | Experimental | HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM) Receives: 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) 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
The rate of change in muscle tension measured by MAS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start4 Mar 2022
- Primary completion3 Jan 2023
- Study completion7 Mar 2023
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289921
- Sponsor's protocol ID
- HU-014_P3_ULS
- Acronym
- HU-014
- Status last verified
- Jul 2023
- First submitted
- 10 Mar 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No