NCT07292025CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
Phase 1 trial to evaluate the safety and efficacy of JTM201 compared with 'Botox® Inj.' in subjects with post-stroke upper limb spasticity
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 24 Nov 2025
- Start date
- 29 Jun 2023
- Primary completion date
- 22 Apr 2024
- Lead sponsor
- Jetema Co., Ltd.
- Diseases
- Stroke
- NCT number
- NCT07292025
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 29 Jun 2023 to the primary completion date, 22 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any medical condition that may affect neuromuscular function (eg, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis)
- Subjects with skin abnormalities such as infection, skin disease, or scar at the planned injection sites
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul Boramae Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.