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New shot takes on botox for Post-Stroke arm tightness

NCT ID NCT07292025

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new drug called JTM201 against Botox in 30 adults who had a stroke at least 6 months ago and still have muscle stiffness in their arm. The goal was to see if JTM201 is safe and can reduce spasticity, making daily tasks like dressing and hygiene easier. The study is already completed, and results will show how it compares to the standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JTM201 (a botulinum toxin type A injection, similar to Botox)
What this could lead to
If it works, JTM201 could offer a new option to ease muscle stiffness in the arm after a stroke, improving daily function.
What could go wrong
This is a very early Phase 1 trial with only 30 people, so results may not apply widely. It compares JTM201 to Botox, so it may not prove better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

Jun 2023

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Seoul Boramae Hospital

    Seoul, South Korea