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

NCT07292025 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-18

No results posted yet for this study

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

Interventions

DRUG

JTM201 in normal saline

Max 360 U of Test drug IM

DRUG

BOTOX 100U in normal saline

Max 360 U of BOTOX IM

Sponsors & Collaborators

  • Jetema Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-29
Primary Completion
2024-04-22
Completion
2024-09-04

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292025 on ClinicalTrials.gov