Could a pill calm Post-Stroke muscle spasms? new trial investigates
NCT ID NCT07704840
First seen Jul 15, 2026 · Last updated Jul 30, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether an oral drug called BMS-986368 can reduce spasticity—muscle tightness and spasms—in adults who had a stroke 4 to 18 months ago. The drug works by boosting natural compounds in the body that calm overactive nerves. Researchers will measure changes in muscle stiffness and arm function, and monitor safety, comparing the drug against a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called BMS-986368, a FAAH/MAGL inhibitor that increases natural calming compounds in the body
- What this could lead to
- If it works, this could offer a new oral treatment option for people with persistent muscle stiffness after a stroke.
- What could go wrong
- This is an early pilot study with only 42 participants, so results may not apply broadly. The drug may not prove effective or could have side effects.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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18 to 80 years
- 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: * Ischemic or hemorrhagic stroke diagnosis 4 to 18 months prior to enrollment. * History of post stroke spasticity for at least 2 months prior to Screening Visit. * Modified Ashworth Scale (mAS) score ≥2 and \<4 for affected elbow and wrist joints at Screen and Baseline Visits. * Fugl-Meyer Assessment for Upper Extremity (FMA-UE) greater than 22 at Screen and Baseline Visits * Willing to participate with no therapy additions during study duration. * Participant must be able to read, speak, and understand English usage Exclusion Criteria: Individuals who are pregnant or breastfeeding. * Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity. * Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse. * Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out prior to randomization. * Participants must not have used FAAH/MAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to randomization. * Other protocol-defined Inclusion/Exclusion criteria apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jeffersi=on Moss Magee Rehabilitation
RECRUITINGElkins Park, Pennsylvania, 19027, United States
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Other studies related to the condition(s) this trial covers.
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- Can a simple TENS device loosen stiff muscles in stroke survivors?
- Could a zap to the wrist ease stroke stiffness?
- Simple decision tree could help stroke patients get faster care for muscle stiffness
- Shock waves may ease stroke stiffness