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

NCT ID: NCT07292025

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-29
• Study Completion Date: 2024-09-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

JTM201

Group Type: EXPERIMENTAL

JTM201 in normal saline

Intervention Type: DRUG

Max 360 U of Test drug IM

Botox

Group Type: ACTIVE_COMPARATOR

BOTOX 100U in normal saline

Intervention Type: DRUG

Max 360 U of BOTOX IM

Interventions

JTM201 in normal saline

Max 360 U of Test drug IM

Intervention Type: DRUG

BOTOX 100U in normal saline

Max 360 U of BOTOX IM

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jetema Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul Boramae Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

JTM201-ULP1

Identifier Type: -

Identifier Source: org_study_id