A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

Post Stroke Upper Limb Spasticity Clinical Trial

Official title:

A Single Center, Phase I Clinical Trial to Evaluate the Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04415346
• Other study ID #: HU-014_P1_ULS
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: November 6, 2019
• Est. completion date: October 2020

Study information

• Verified date: May 2020
• Source: Huons Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 13
• Est. completion date: October 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Post Stroke Upper Limb Spasticity
• Stroke

Intervention

Biological:
• HU-014 Inj
Clostridium botulinum type A

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Huons Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAS score improvement at Wrist Flexor, Elbow Flexor, Finger Flexor	The rate of change in muscle tension measured by MAS	Week 4, 8, 12 from baseline visit(=Investigational product Injection)