Upper Limb Spasticity Post-StrokePhase 1NCT07292025
Phase 1 Trial of JTM201 in Subjects With Post-stroke Upper Limb Spasticity
A Phase 1 study testing JTM201 in normal saline and BOTOX 100U in normal saline in people with Upper Limb Spasticity Post-Stroke, run by Jetema Co., Ltd. at 1 site in South Korea.
Trial summary
Phase 1 trial to evaluate the safety and efficacy of JTM201 compared with 'Botox® Inj.' in subjects with post-stroke upper limb spasticity Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Upper Limb Spasticity Post-Stroke
- What is being tested?
- JTM201 in normal saline and BOTOX 100U in normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2023to 4 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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]
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- JTM201 in normal saline, BOTOX 100U in normal saline
- Keywords
- ULP, upper limb spasticity post-stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTM201 in normal salineDrug
Max 360 U of Test drug IM
BOTOX 100U in normal salineDrug
Max 360 U of BOTOX IM
| Study group | Role | What they receive |
|---|---|---|
| JTM201 | Experimental | Not described Receives: Drug: JTM201 in normal saline |
| Botox | Active comparator | Not described Receives: Drug: BOTOX 100U in normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start29 Jun 2023
- Primary completion22 Apr 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Spasticity Post-StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jetema Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292025
- Sponsor's protocol ID
- JTM201-ULP1
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07292025
- Acronym / sponsor ID
- JTM201-ULP1
- Conditions
- Upper Limb Spasticity Post-Stroke
- Keywords
- ULP, upper limb spasticity post-stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jetema Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 trial to evaluate the safety and efficacy of JTM201 compared with 'Botox® Inj.' in subjects with post-stroke upper limb spasticity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JTM201 | Experimental | Drug: JTM201 in normal saline |
| Botox | Active comparator | Drug: BOTOX 100U in normal saline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JTM201 in normal salineMax 360 U of Test drug IM | Drug | JTM201 |
| BOTOX 100U in normal salineMax 360 U of BOTOX IM | Drug | Botox |
Primary outcome
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.
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.
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.
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JTM201 in normal saline and BOTOX 100U in normal saline in people with Upper Limb Spasticity Post-Stroke, run by Jetema Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Modified Ashworth Scale score of Wrist Flexor (time frame: Week 4, Week 8, Week 12). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.