[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07704840":3,"trial-entities:NCT07704840":146,"trial-summary:NCT07704840":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":49,"sex":98,"minimum_age":99,"maximum_age":100,"healthy_volunteers":14,"eligibility_criteria":101,"std_ages":115,"locations":118,"central_contacts":137,"overall_officials":140,"references":144,"see_also_links":145},"NCT07704840","iRISID-2026-0193","A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH\u002FMAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)","A Phase 2, Randomized, Double-blind, Placebo-controlled Pilot Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH\u002FMAGL Inhibitor, for the Treatment of Spasticity in Participants With Post-stroke Spasticity","RECRUITING","2027-08","2026-07","2026-07-29","Alberto Esquenazi","OTHER",false,"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","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:\n\n* A screening period of up to 4 weeks\n* An 8-week double-blind treatment period\n* An optional 8-week double-blind active treatment extension (DBATE)\n* 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",[18],"Post-Stroke Spasticity",[20,21,22,23],"Stroke","Spasticity","Neurological Disorders","Upper Limb Spasticity","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},42,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Administration of BMS-986368","Administration of BMS-986368. Specified dose on specified days",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Placebo","Interventions:\n\nDrug: Placebo",[38],[42,46],{"measure":43,"description":44,"timeFrame":45},"Tardieu Scale","Change from baseline in elbow and wrist Tardieu Scale. Clinical assessment with higher scores indicating greater spasticity.","At Week 8",{"measure":47,"description":48,"timeFrame":45},"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.",[50,54,57,61,65,69,73,77,80,82,84,87,90,94],{"measure":51,"description":52,"timeFrame":53},"Tardieu Scale - DBATE","Change from baseline in in elbow and wrist Tardieu Scale for participants in the Optional Active Treatment Extension Phase (DBATE).","At week 16",{"measure":55,"description":56,"timeFrame":53},"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)",{"measure":58,"description":59,"timeFrame":60},"Total Numeric-transformed Modified Ashworth Scale (TNmAS)","Change from baseline in Total Numeric-transformed Modified Ashworth Scale; Clinician-rated measure of muscle tone\u002Fspasticity.","At week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension phase",{"measure":62,"description":63,"timeFrame":64},"Numeric Rating Scale - Spasticity (NRS-S)","Change from baseline. Participant-rated severity of spasticity on a 0-10 scale","At Week 8 for all participants. At Week 16 for participants in the Optional Active Treatment Extension Phase",{"measure":66,"description":67,"timeFrame":68},"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\u002F","At Week 8 for all participants Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase",{"measure":70,"description":71,"timeFrame":72},"Clinical Global Impression of Severity (CGI-S)","Change from baseline on the Clinical Global Impression of Severity (CGI-S) score.\n\nClinician assessment of overall severity of spasticity-related impairment.","At Week 8 for all participants. Additionally at Week 16 for participants in the Optional Active Treatment Extension Phase",{"measure":74,"description":75,"timeFrame":76},"Treatment-Emergent Adverse Events (TEAEs)","Number of participants with Treatment-Emergent Adverse Events (TEAEs)","Up to week 16]",{"measure":78,"description":78,"timeFrame":79},"Serious adverse events (SAEs)","Up to week 16",{"measure":81,"description":81,"timeFrame":76},"Adverse events (AEs) leading to treatment discontinuation",{"measure":83,"description":83,"timeFrame":76},"AEs leading to death",{"measure":85,"description":85,"timeFrame":86},"AEs leading to clinically significant lab abnormalities","[Time Frame: Up to week 16]",{"measure":88,"description":89,"timeFrame":76},"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).",{"measure":91,"description":92,"timeFrame":93},"Cannabis Withdrawal Symptoms","Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS).","Up to week 24",{"measure":95,"description":96,"timeFrame":97},"Plasma concentrations of BMS-986368","Plasma concentrations of BMS-986368 at selected pre- and post-dose time points","Up to Week 8","ALL","18 Years","80 Years",{"inclusion":102,"exclusion":109,"raw_text":114},[103,104,105,106,107,108],"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 \\\u003C4 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",[110,111,112,113],"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\u002FMAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to randomization.","Inclusion Criteria:\n\n* Ischemic or hemorrhagic stroke diagnosis 4 to 18 months prior to enrollment.\n* History of post stroke spasticity for at least 2 months prior to Screening Visit.\n* Modified Ashworth Scale (mAS) score ≥2 and \\\u003C4 for affected elbow and wrist joints at Screen and Baseline Visits.\n* Fugl-Meyer Assessment for Upper Extremity (FMA-UE) greater than 22 at Screen and Baseline Visits\n* Willing to participate with no therapy additions during study duration.\n* Participant must be able to read, speak, and understand English usage\n\nExclusion Criteria:\n\nIndividuals who are pregnant or breastfeeding.\n\n* Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity.\n* 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.\n* Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out prior to randomization.\n* Participants must not have used FAAH\u002FMAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to randomization.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",[116,117],"ADULT","OLDER_ADULT",[119],{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":124,"contacts":125,"geoPoint":134},"Jeffersi=on Moss Magee Rehabilitation","Elkins Park","Pennsylvania","19027","United States",[126,131],{"name":127,"role":128,"phone":129,"email":130},"Kareema Murray","CONTACT","215-663-6290","Kareema.Murray@jefferson.edu",{"name":132,"role":133},"Alberto Esquenazi, MD","PRINCIPAL_INVESTIGATOR",{"lat":135,"lon":136},40.07706,-75.12684,[138],{"name":127,"role":128,"phone":129,"email":139},"kareema.murray@jefferson.edu",[141],{"name":132,"affiliation":142,"role":143},"Thomas Jefferson University","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":147,"biomarkers":148},[18,20],[],{"nct_id":4,"found":150,"summary":151,"prompt_version":161},true,{"design":152,"status":153,"heading":154,"summary":155,"follow_up":156,"word_count":157,"commitments":158,"compensation":159,"drugs_mentioned":160},"This is a pilot study, meaning it's an early look at the drug. It's a randomized, double-blind, placebo-controlled trial, which means some participants will receive the drug and others a placebo, and neither you nor your doctor will know which you are receiving. It plans to enroll 42 participants.","completed","The STIPS Study: BMS-986368 for Post-Stroke Spasticity","This study is testing a drug called BMS-986368 to see if it can help adults who have muscle stiffness and spasms (spasticity) after a stroke. BMS-986368 is designed to increase natural body compounds that may calm nerves causing tight muscles. The study will also look at how safe BMS-986368 is. You might be able to join if you are 18 to 80 years old, had a stroke 4 to 18 months ago, and have had post-stroke spasticity for at least two months. The researchers will measure changes in your muscle stiffness using scales like the Tardieu Scale and the Upper Limb Fugl-Meyer Assessment (FMA-UE) after 8 weeks to see if the drug is working. The current recruitment status is unclear.","Participants will have a 4-week safety follow-up period after treatment.",120,"You would have a screening period of up to 4 weeks, followed by an 8-week treatment period. There's an optional 8-week extension and a 4-week safety follow-up, making the maximum study duration about 24 weeks.","Not stated in the trial record.",[],"v2"]