Status:
UNKNOWN
A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
Lead Sponsor:
Huons Co., Ltd.
Conditions:
Post Stroke Upper Limb Spasticity
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief 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 * Sit...
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 :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04415346
Start Date
November 6 2019
End Date
October 1 2020
Last Update
June 4 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505