New shot takes on botox for Post-Stroke arm tightness
NCT ID NCT07292025
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Sep 2024
- Lead sponsor
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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
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Seoul Boramae Hospital
Seoul, South Korea