A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
Alberto Esquenazi · Other
Who this trial is looking for
This trial is looking for adults who have had a stroke and are experiencing tightness or spasms in their muscles. Participants will help researchers learn about the safety and effectiveness of a new drug called BMS-986368.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke 4 to 18 months ago.
I have had muscle tightness or spasms for at least 2 months.
My modified Ashworth Scale (mAS) score is between 2 and 4 for my elbow and wrist.
My Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score is greater than 22.
I agree not to add any new therapies during the study.
I can read, speak, and understand English.
You may not be able to join if
I am pregnant or breastfeeding.
I have a disease or disorder that causes symptoms of spasticity.
I have a history of substance abuse disorder.
I am currently taking medication for spasticity that cannot be stopped.
I have used any FAAH/MAGL inhibitor or cannabinoid products in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The goal of this clinical trial is to learn if the drug BMS-986368 works to treat post stroke spasticity in adults who have had a stroke. BMS-986368 is a designed to increase natural compounds in the body that may help calm nerves that cause muscles to be tight or spasm. The study will also learn about the safety of drug BMS-986368
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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.
…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
