Post-Stroke SpasticityPhase 2STIPSNCT07704840
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)
A Phase 2 study testing Administration of BMS-986368 in people with Post-Stroke Spasticity, run by Alberto Esquenazi at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-Stroke Spasticity
- What is being tested?
- Administration of BMS-986368
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2026to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jeffersi=on Moss Magee Rehabilitation
Elkins Park, Pennsylvania, 19027
Kareema Murray, 215-663-6290, Kareema.Murray@jefferson.edu
Alberto Esquenazi, MD
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Pilot Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Post-stroke Spasticity
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
Read the detailed description
Post-stroke spasticity (PSS) is a common and disabling complication of stroke that can impair upper-limb function, limit activities of daily living, and negatively affect quality of life. Current treatment options, including oral antispasticity medications and botulinum toxin injections, may provide incomplete symptom control and are often associated with tolerability limitations. Therefore, there is a need for novel therapies that can improve both spasticity and functional recovery in individuals with PSS. Preclinical evidence and early clinical experience support evaluation of BMS-986368 as a treatment for post-stroke spasticity. The STIPS Study is a Phase 2, randomized, double-blind, placebo-controlled pilot trial designed to evaluate the efficacy, safety, and tolerability of BMS-986368 in adults with post-stroke spasticity. The study consists of:
- A screening period of up to 4 weeks
- An 8-week double-blind treatment period
- An optional 8-week double-blind active treatment extension (DBATE)
- A 4-week safety follow-up period The maximum study duration is approximately 24 weeks. During the double-blind treatment period, participants randomized to active treatment will receive oral BMS-986368 with dose escalation from 1 mg once daily, to 3 mg once daily and then 6 mg once daily. Participants randomized to placebo will receive matching placebo capsules. Participants who complete the double-blind treatment period may elect to enter the DBATE, during which all participants receive active treatment while maintaining study blinding. The study hypothesis is that BMS-986368 administered up to 6 mg once daily will result in greater improvement in spasticity and upper-extremity motor function compared with placebo, while demonstrating an acceptable safety and tolerability profile in participants with post-stroke spasticity
- Conditions
- Post-Stroke Spasticity
- Being tested
- Administration of BMS-986368, Placebo
- Keywords
- Stroke, Spasticity, Neurological Disorders, Upper Limb Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of BMS-986368Drug
Administration of BMS-986368. Specified dose on specified days
PlaceboDrug
Interventions:
Drug: Placebo
| Study group | Role | What they receive |
|---|---|---|
| Administration of BMS-986368 | Experimental | Drug: BMS-986368. Specified dose on specified days Receives: Drug: Administration of BMS-986368 |
| Placebo | Placebo comparator | Drug: Placebo Specified dose on specified days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tardieu Scale
Change from baseline in elbow and wrist Tardieu Scale. Clinical assessment with higher scores indicating greater spasticity.
Measured: At Week 8
Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale
Change from baseline, Clinical Assessment of upper-extremity motor function and sensorimotor recovery after stroke. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: At Week 8
Secondary outcomes (14)
Tardieu Scale - DBATE
Change from baseline in in elbow and wrist Tardieu Scale for participants in the Optional Active Treatment Extension Phase (DBATE).
Measured: At week 16
Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale- DBATE
Change from baseline iat Week 16 for patients in the for patients in the Optional Active Treatment Extension Phase (DBATE)
Measured: At week 16
Total Numeric-transformed Modified Ashworth Scale (TNmAS)
Change from baseline in Total Numeric-transformed Modified Ashworth Scale; Clinician-rated measure of muscle tone/spasticity.
Measured: At week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension phase
Numeric Rating Scale - Spasticity (NRS-S)
Change from baseline. Participant-rated severity of spasticity on a 0-10 scale
Measured: At Week 8 for all participants. At Week 16 for participants in the Optional Active Treatment Extension Phase
Patient Health Questionnaire-9 (PHQ-9)
Change from baseline in PHQ-9 Depression Scale. .The PHQ-9 participant-reported questionnaire used to assess the severity of depressive symptoms/
Measured: At Week 8 for all participants Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase
Clinical Global Impression of Severity (CGI-S)
Change from baseline on the Clinical Global Impression of Severity (CGI-S) score.
Clinician assessment of overall severity of spasticity-related impairment.
Measured: At Week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase
Treatment-Emergent Adverse Events (TEAEs)
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to week 16]
Serious adverse events (SAEs)
Serious adverse events (SAEs)
Measured: Up to week 16
Adverse events (AEs) leading to treatment discontinuation
Adverse events (AEs) leading to treatment discontinuation
Measured: Up to week 16]
AEs leading to death
AEs leading to death
Measured: Up to week 16]
AEs leading to clinically significant lab abnormalities
AEs leading to clinically significant lab abnormalities
Measured: [Time Frame: Up to week 16]
Suicidal Ideation and Behavior
Number of participants with suicidal ideation and behavior during trial as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
Measured: Up to week 16]
Cannabis Withdrawal Symptoms
Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS).
Measured: Up to week 24
Plasma concentrations of BMS-986368
Plasma concentrations of BMS-986368 at selected pre- and post-dose time points
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start2 Sep 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke SpasticityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberto Esquenazi
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Alberto Esquenazi, Thomas Jefferson University
- Investigators
- Alberto Esquenazi, MD, Study director, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704840
- Sponsor's protocol ID
- iRISID-2026-0193
- Other IDs
- IM045-1032
- Acronym
- STIPS
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our intention is to provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. However, we are answering this item as "undecided" while specific details are determined.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Pilot Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Post-stroke Spasticity
- ClinicalTrials.gov ID
- NCT07704840
- Acronym / sponsor ID
- STIPS / iRISID-2026-0193
- Conditions
- Post-Stroke Spasticity
- Keywords
- Stroke, Spasticity, Neurological Disorders, Upper Limb Spasticity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Alberto EsquenaziUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jul 2026 (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.
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
Detailed description
Post-stroke spasticity (PSS) is a common and disabling complication of stroke that can impair upper-limb function, limit activities of daily living, and negatively affect quality of life. Current treatment options, including oral antispasticity medications and botulinum toxin injections, may provide incomplete symptom control and are often associated with tolerability limitations. Therefore, there is a need for novel therapies that can improve both spasticity and functional recovery in individuals with PSS. Preclinical evidence and early clinical experience support evaluation of BMS-986368 as a treatment for post-stroke spasticity. The STIPS Study is a Phase 2, randomized, double-blind, placebo-controlled pilot trial designed to evaluate the efficacy, safety, and tolerability of BMS-986368 in adults with post-stroke spasticity. The study consists of:
- A screening period of up to 4 weeks
- An 8-week double-blind treatment period
- An optional 8-week double-blind active treatment extension (DBATE)
- A 4-week safety follow-up period The maximum study duration is approximately 24 weeks. During the double-blind treatment period, participants randomized to active treatment will receive oral BMS-986368 with dose escalation from 1 mg once daily, to 3 mg once daily and then 6 mg once daily. Participants randomized to placebo will receive matching placebo capsules. Participants who complete the double-blind treatment period may elect to enter the DBATE, during which all participants receive active treatment while maintaining study blinding. The study hypothesis is that BMS-986368 administered up to 6 mg once daily will result in greater improvement in spasticity and upper-extremity motor function compared with placebo, while demonstrating an acceptable safety and tolerability profile in participants with post-stroke 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 |
|---|---|---|
| Administration of BMS-986368 | Experimental | Drug: Administration of BMS-986368Drug: BMS-986368. Specified dose on specified days |
| Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo Specified dose on specified days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Administration of BMS-986368Administration of BMS-986368. Specified dose on specified days | Drug | Administration of BMS-986368 |
| PlaceboInterventions: Drug: Placebo | Drug | Placebo |
Primary outcome
Tardieu Scale
Time frame: At Week 8
Change from baseline in elbow and wrist Tardieu Scale. Clinical assessment with higher scores indicating greater spasticity.
Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale
Time frame: At Week 8
Change from baseline, Clinical Assessment of upper-extremity motor function and sensorimotor recovery after stroke. Scores range from 0 to 66, with higher scores indicating better motor function.
14 secondary outcomes
Tardieu Scale - DBATE
Time frame: At week 16
Upper Limb Fugl-Meyer Assessment (FMA-UE) Scale- DBATE
Time frame: At week 16
Total Numeric-transformed Modified Ashworth Scale (TNmAS)
Time frame: At week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension phase
Numeric Rating Scale - Spasticity (NRS-S)
Time frame: At Week 8 for all participants. At Week 16 for participants in the Optional Active Treatment Extension Phase
Patient Health Questionnaire-9 (PHQ-9)
Time frame: At Week 8 for all participants Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase
Clinical Global Impression of Severity (CGI-S)
Time frame: At Week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase
Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to week 16]
Serious adverse events (SAEs)
Time frame: Up to week 16
Adverse events (AEs) leading to treatment discontinuation
Time frame: Up to week 16]
AEs leading to death
Time frame: Up to week 16]
AEs leading to clinically significant lab abnormalities
Time frame: [Time Frame: Up to week 16]
Suicidal Ideation and Behavior
Time frame: Up to week 16]
Cannabis Withdrawal Symptoms
Time frame: Up to week 24
Plasma concentrations of BMS-986368
Time frame: Up to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Undecided. Our intention is to provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. However, we are answering this item as "undecided" while specific details are determined.
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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.
Alberto Esquenazi, MD study director
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of BMS-986368 in people with Post-Stroke Spasticity, run by Alberto Esquenazi at 1 site in United States.
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 6 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kareema Murray (215-663-6290, kareema.murray@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tardieu Scale (time frame: At Week 8). The study lists 2 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 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.