Status:
COMPLETED
To Evaluate HU-014 in the Treatment of Post Stroke Upper Limb
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Post Stroke Upper Limb Spasticity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Spastici...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2023
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT05289921
Start Date
March 4 2022
End Date
March 7 2023
Last Update
August 1 2023
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea