Skip to main content
OpenTrials
Completed

NCT Number: NCT07292025

Phase 1 Trial 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Upper Limb Spasticity Post-Stroke

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul Boramae Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JTM201 in normal saline

Drug

Max 360 U of Test drug IM

BOTOX 100U in normal saline

Drug

Max 360 U of BOTOX IM

Primary outcomes

  1. Change from baseline in Modified Ashworth Scale score of Wrist Flexor

    Time frame: Week 4, Week 8, Week 12

    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.

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

    Time frame: Week 4, Week 8, Week 12

    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.

  3. 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

    Time frame: Week 4, Week 8, Week 12

    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.

  4. Changes from baseline in Disability Assessment Scale score

    Time frame: Week 4, Week 8, Week 12

    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.

  5. Global Assessment Scale evaluated by investigator

    Time frame: Week 4, Week 8, Week 12

    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.

  6. Global Assessment Scale evaluated by patients

    Time frame: Visit 3, 4, 5

    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.

  7. Change from baseline in Caregiver Burden Scale completed by caregiver

    Time frame: Week 4, Week 8, Week 12

    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).

Sponsors and collaborators

Lead sponsor

Jetema Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.