Phase 1 Trial of JTM201 in Subjects With Post-stroke Upper Limb Spasticity

NCT07292025 | Completed Phase 1

• 1 other identifier: JTM201-ULP1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 trial to evaluate the safety and efficacy of JTM201 compared with 'Botox® Inj.' in subjects with post-stroke upper limb spasticity

Conditions

Upper Limb Spasticity Post-Stroke

Keywords

ULP; upper limb spasticity post-stroke

Outcome Measures

Primary Outcomes (7)

• Change from baseline in Modified Ashworth Scale score of Wrist Flexor

  The Modified Ashworth Scale (MAS), a clinical scale used to assess muscle spasticity, was administered with the subject placed in a supine position. The investigator performing the assessment was required to be adequately trained and familiar with the MAS grading criteria, and the same evaluator was used throughout the clinical study whenever possible.

  Week 4, Week 8, Week 12

• Change from baseline in Modified Ashworth Scale score of Elbow Flexor, Finger Flexor

  The Modified Ashworth Scale (MAS), a clinical scale used to assess muscle spasticity, was administered with the subject placed in a supine position. The investigator performing the assessment was required to be adequately trained and familiar with the MAS grading criteria, and the same evaluator was used throughout the clinical study whenever possible.

  Week 4, Week 8, Week 12

• Proportion of subjects with at least 1-point improvement from baseline in the Modified Ashworth Scale score for the Wrist Flexor, Elbow Flexor, Finger Flexor

  The Modified Ashworth Scale (MAS), a clinical scale used to assess muscle spasticity, was administered with the subject placed in a supine position. The investigator performing the assessment was required to be adequately trained and familiar with the MAS grading criteria, and the same evaluator was used throughout the clinical study whenever possible.

  Week 4, Week 8, Week 12

• Changes from baseline in Disability Assessment Scale score

  The Disability Assessment Scale (DAS) was evaluated by the investigator through an interview with the subject. The assessment was performed by the same investigator throughout the clinical study whenever possible to assess Hygiene, Dressing, Limb Position, and Pain.

  Week 4, Week 8, Week 12

• Global Assessment Scale evaluated by investigator

  The overall improvement in muscle stiffness was assessed using the Global Assessment Scale (GAS) by both the investigator and the subject at Weeks 4, 8, and 12 after administration of the investigational product.

  Week 4, Week 8, Week 12

• Global Assessment Scale evaluated by patients

  The overall improvement in muscle stiffness was assessed using the Global Assessment Scale (GAS) by both the investigator and the subject at Weeks 4, 8, and 12 after administration of the investigational product.

  Visit 3, 4, 5

• Change from baseline in Caregiver Burden Scale completed by caregiver

  The Caregiver Burden Scale, a tool used to assess the level of caregiver assistance required for activities of daily living, was evaluated using a 5-point Likert scale for four tasks related to the affected arm (arm with spasticity).

  Week 4, Week 8, Week 12

Study Arms (2)

JTM201

EXPERIMENTAL

Drug: JTM201 in normal saline

Botox

ACTIVE COMPARATOR

Drug: BOTOX 100U in normal saline

Interventions

JTM201 in normal saline DRUG

Max 360 U of Test drug IM

JTM201

BOTOX 100U in normal saline DRUG

Max 360 U of BOTOX IM

Botox

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects (or legal representatives) who voluntarily decided the participation of the study and provide written informed consent
• Subjects ≥ 19 years of age, inclusive
• Subjects who was diagnosed stroke at least 6 months prior to screening
• Subjects with MAS score with the wrist flexor score ≥2 and at least one of the elbow flexor or finger flexor score ≥1
• Subjects with a Disability Assessment Scale (DAS) score ≥2 in at least one functional domain, hygiene, dressing, limb position, or pain, selected as the primary treatment goal
• Female subjects who are non-childbearing potential, or childbearing\* subjects who are not pregnant, or breastfeeding, a negative serum pregnancy result during screening, and women and men of childbearing potential who agree to use medically acceptable contraceptive methods\*\* or to be sexual abstinence during the study period

You may not qualify if:

• Any medical condition that may affect neuromuscular function (eg, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
• Subjects with dysphagia that, in the judgment of the investigator, may interfere with study participation
• Subjects with fixed joint/muscle contracture\* at the planned injection sites
• Subjects with severe muscle atrophy at the planned injection sites
• Subjects with skin abnormalities such as infection, skin disease, or scar at the planned injection sites
• History of acute deterioration in pulmonary function within 3 months prior to screening \[including but not limited to hospitalization due to asthma or COPD exacerbation, or pneumonia\]
• History of chemodenervation using phenol or alcohol, or surgery at the planned injection site within 24 weeks prior to screening, or scheduled for treatment or surgical intervention during the study
• History of tendon lengthening of the study limb within 24 weeks prior to screening, or scheduled surgical intervention at the planned injection site during the study
• Previous treatment with botulinum toxin of any serotype in any area within 24 weeks prior to screening
• Subjects with ongoing treatment with intrathecal Baclofen
• Subjects who require the administration of concomitant medications or implementation of concomitant therapies during the study period

Sponsors & Collaborators

• Jetema Co., Ltd.: lead

Study Sites (1)

Seoul Boramae Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Saline Solution; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: June 29, 2023
• Primary Completion: April 22, 2024
• Study Completion: September 4, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)