Post Stroke Upper Limb Spasticity
Conditions
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 * 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
Interventions
BIOLOGICALHU-014 Inj
Clostridium botulinum type A
Sponsors
Huons Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor | Week 4, 8, 12 from baseline visit(=Investigational product Injection) | The rate of change in muscle tension measured by MAS |
Countries
South Korea
Outcome results
None listed