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

A Randomized, Double-blind, Active-controlled, Multicenter, Phase 1 Trial to Investigate the Safety and Efficacy of JTM201 in Subjects With Post-stroke Upper Limb Spasticity

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

Study Overview

• Status: Completed
• Conditions: Upper Limb Spasticity Post-Stroke
• Intervention / Treatment: Drug: JTM201 in normal saline; Drug: BOTOX 100U in normal saline

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Seoul Boramae Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botox	Drug: BOTOX 100U in normal saline; Max 360 U of BOTOX IM
Experimental: JTM201	Drug: JTM201 in normal saline; Max 360 U of Test drug IM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jetema Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Actual): April 22, 2024
• Study Completion (Actual): September 4, 2024

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ULP; upper limb spasticity post-stroke
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Pharmaceutical Preparations; Biological Factors; Hydrolases; Enzymes; Enzymes and Coenzymes; Crystalloid Solutions; Isotonic Solutions; Solutions; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Metalloproteases; Bacterial Proteins; Bacterial Toxins; Toxins, Biological; Botulinum Toxins, Type A; Saline Solution
• Other Study ID Numbers: JTM201-ULP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No