Last updated: July 30, 2023
Sponsor: Huons Co., Ltd.
Overall Status: Completed
Phase
3
Condition
Stroke
Limb Spasticity
Cerebral Ischemia
Treatment
HU-014 Inj
Clinical Study ID
NCT05289921
HU-014_P3_ULS
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 andFlexor or Finger Flexor is ≥ 1.
- A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of thecategories of hand hygiene, clothing, upper extremity, or pain for evaluation.
Exclusion
Exclusion Criteria:
- A subject who has medical history following. (Allergy, Chemodenervation(within 6months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspirationpneumonia, etc.)
- A subject who has history of any diseases following. (neuromuscular junction disorder,NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateralsclerosis, ALS, Skin disease, Dysphagia, etc.)
- From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesisimplantation 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 isscheduled to be administered.
- A sugject who has muscle atrophy, fixed joint/muscle contracture in the area wheremedication for clinical trials is scheduled to be administered.
- Any condition that, in the view of the investigator, would interfere with studyparticipation.
Study Design
Total Participants: 198
Treatment Group(s): 1
Primary Treatment: HU-014 Inj
Phase: 3
Study Start date:
March 04, 2022
Estimated Completion Date:
March 07, 2023
Connect with a study center
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
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