[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06226805":3,"trial-entities:NCT06226805":336,"trial-summary:NCT06226805":340},{"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":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":51,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":79,"locations":82,"central_contacts":322,"overall_officials":327,"references":334,"see_also_links":335},"NCT06226805","BB-031-CLIN-201","Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)","A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients","RECRUITING","2027-09","2026-05","2026-05-14","2024-07-31","Basking Biosciences, Inc.","INDUSTRY",true,"The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset.\n\nParticipants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 228 patients are planned in this study.","This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, up to 48 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 180 participants will be randomized to receive a single dose of two sequential dose levels of study drug or placebo.\n\nAll participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study as outlined in the protocol.",[19],"Acute Ischemic Stroke",[21,22,23,24],"Stroke","Wake-up stroke","Large vessel occlusion","Intracranial hemorrhage","INTERVENTIONAL","PREVENTION",[28],"PHASE2",{"count":30,"type":31},228,"ESTIMATED",[33,40],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","BB-031","Solution for injection",[35],[39],"DTRI-031",{"type":34,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Placebo","0.9% sodium chloride for injection",[41],[45],"Saline",[47],{"measure":48,"description":49,"timeFrame":50},"Symptomatic Intracranial Hemorrhage (sICH)","Proportion of participants having a sICH","24 hours",[52,55],{"measure":53,"description":54,"timeFrame":50},"Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)","Proportion of participants having a non-symptomatic-ICH",{"measure":56,"description":57,"timeFrame":50},"Adverse Events (AEs)","Incidence and severity of treatment-emergent AEs","ALL","18 Years",null,false,{"inclusion":63,"exclusion":69,"raw_text":78},[64,65,66,67,68],"Clinical diagnosis of acute ischemic stroke","18 years or older","Anterior circulation intra-cranial occlusion","NIHSS score \\>3","Onset of stroke symptoms within 24 hours of enrollment",[70,71,72,73,74,75,76,77],"Large volume ischemic stroke","Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage","Chronic intracranial occlusion","Weight \\>125kg","Administration of thrombolytic drug or glycoprotein IIb\u002FIIIa inhibitors","Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding","Prior stroke within 90 days","Unable to undergo a contrast brain perfusion scan with either MRI or CT","Inclusion Criteria:\n\n* Clinical diagnosis of acute ischemic stroke\n* 18 years or older\n* Anterior circulation intra-cranial occlusion\n* NIHSS score \\>3\n* Onset of stroke symptoms within 24 hours of enrollment\n\nExclusion Criteria:\n\n* Large volume ischemic stroke\n* Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage\n* Chronic intracranial occlusion\n* Weight \\>125kg\n* Administration of thrombolytic drug or glycoprotein IIb\u002FIIIa inhibitors\n* Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding\n* Prior stroke within 90 days\n* Unable to undergo a contrast brain perfusion scan with either MRI or CT",[80,81],"ADULT","OLDER_ADULT",[83,96,105,112,119,128,137,147,157,167,177,187,196,202,212,221,232,242,252,262,271,281,292,301,312],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":93},"HonorHealth Bob Bove Neuroscience Institute","Scottsdale","Arizona","85251","United States",[90],{"name":91,"role":92},"Study Coordinator","CONTACT",{"lat":94,"lon":95},33.50921,-111.89903,{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":88,"geoPoint":102},"Mills Peninsula Medical Center","WITHDRAWN","Burlingame","California","94010",{"lat":103,"lon":104},37.5841,-122.36608,{"facility":106,"status":98,"city":107,"state":100,"zip":108,"country":88,"geoPoint":109},"MemorialCare Long Beach Medical Center","Long Beach","90806",{"lat":110,"lon":111},33.76696,-118.18923,{"facility":113,"status":98,"city":114,"state":100,"zip":115,"country":88,"geoPoint":116},"California Pacific Medical Center","San Francisco","94109",{"lat":117,"lon":118},37.77493,-122.41942,{"facility":120,"status":8,"city":121,"state":100,"zip":122,"country":88,"contacts":123,"geoPoint":125},"Pacific Neurosciences Institute at Saint John's Physician Partners","Torrance","90503",[124],{"name":91,"role":92},{"lat":126,"lon":127},33.83585,-118.34063,{"facility":129,"status":130,"city":131,"state":132,"zip":133,"country":88,"geoPoint":134},"Baptist Health Medical Center","TERMINATED","Jacksonville","Florida","32207",{"lat":135,"lon":136},30.33218,-81.65565,{"facility":138,"status":8,"city":139,"state":140,"zip":141,"country":88,"contacts":142,"geoPoint":144},"Henry Ford Hospital","Detroit","Michigan","48202",[143],{"name":91,"role":92},{"lat":145,"lon":146},42.33143,-83.04575,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":88,"contacts":152,"geoPoint":154},"Washington University in St. Louis","St Louis","Missouri","63110",[153],{"name":91,"role":92},{"lat":155,"lon":156},38.62727,-90.19789,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":88,"contacts":162,"geoPoint":164},"Cooper University Hospital","Camden","New Jersey","08103",[163],{"name":91,"role":92},{"lat":165,"lon":166},39.92595,-75.11962,{"facility":168,"status":8,"city":169,"state":170,"zip":171,"country":88,"contacts":172,"geoPoint":174},"WakeMed","Raleigh","North Carolina","27610",[173],{"name":91,"role":92},{"lat":175,"lon":176},35.7721,-78.63861,{"facility":178,"status":8,"city":179,"state":180,"zip":181,"country":88,"contacts":182,"geoPoint":184},"The Ohio State University","Columbus","Ohio","43210",[183],{"name":91,"role":92},{"lat":185,"lon":186},39.96118,-82.99879,{"facility":188,"status":8,"city":189,"state":180,"zip":190,"country":88,"contacts":191,"geoPoint":193},"ProMedica Toledo Hospital","Toledo","43604",[192],{"name":91,"role":92},{"lat":194,"lon":195},41.66394,-83.55521,{"facility":197,"status":8,"city":189,"state":180,"zip":198,"country":88,"contacts":199,"geoPoint":201},"Mercy Health St. Vincent Medical Center","43608",[200],{"name":91,"role":92},{"lat":194,"lon":195},{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":88,"contacts":207,"geoPoint":209},"Valley Baptist Medical Center - Harlingen","Harlingen","Texas","78550",[208],{"name":91,"role":92},{"lat":210,"lon":211},26.19063,-97.6961,{"facility":213,"status":8,"city":214,"state":205,"zip":215,"country":88,"contacts":216,"geoPoint":218},"Memorial Hermann Hospital","Houston","77030",[217],{"name":91,"role":92},{"lat":219,"lon":220},29.76328,-95.36327,{"facility":222,"status":8,"city":223,"state":224,"zip":225,"country":226,"contacts":227,"geoPoint":229},"John Hunter Hospital","New Lambton Heights","New South Wales","2305","Australia",[228],{"name":91,"role":92},{"lat":230,"lon":231},-32.92466,151.69364,{"facility":233,"status":8,"city":234,"state":235,"zip":236,"country":226,"contacts":237,"geoPoint":239},"Princess Alexandra Hospital","Woolloongabba","Queensland","4102",[238],{"name":91,"role":92},{"lat":240,"lon":241},-27.48855,153.03655,{"facility":243,"status":8,"city":244,"state":245,"zip":246,"country":226,"contacts":247,"geoPoint":249},"Royal Adelaide Hospital","Adelaide","South Australia","5000",[248],{"name":91,"role":92},{"lat":250,"lon":251},-34.92866,138.59863,{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":226,"contacts":257,"geoPoint":259},"Monash Medical Centre","Clayton","Victoria","3168",[258],{"name":91,"role":92},{"lat":260,"lon":261},-37.91667,145.11667,{"facility":263,"status":8,"city":264,"state":255,"zip":265,"country":226,"contacts":266,"geoPoint":268},"The Royal Melbourne Hospital","Parkville","3050",[267],{"name":91,"role":92},{"lat":269,"lon":270},-37.78333,144.95,{"facility":272,"status":8,"city":273,"state":274,"zip":275,"country":226,"contacts":276,"geoPoint":278},"Fiona Stanley Hospital","Murdoch","Western Australia","6150",[277],{"name":91,"role":92},{"lat":279,"lon":280},-32.06987,115.83757,{"facility":282,"status":8,"city":283,"state":284,"zip":285,"country":286,"contacts":287,"geoPoint":289},"University of Calgary","Calgary","Alberta","T2N2T9","Canada",[288],{"name":91,"role":92},{"lat":290,"lon":291},51.05011,-114.08529,{"facility":293,"status":8,"city":294,"state":284,"zip":295,"country":286,"contacts":296,"geoPoint":298},"University of Alberta Hospital","Edmonton","T6G 2G3",[297],{"name":91,"role":92},{"lat":299,"lon":300},53.55014,-113.46871,{"facility":302,"status":8,"city":303,"state":304,"zip":305,"country":286,"contacts":306,"geoPoint":309},"Vancouver Stroke Program","Vancouver","British Columbia","V5Z1M9",[307],{"name":308,"role":92},"Research Coordinator",{"lat":310,"lon":311},49.24966,-123.11934,{"facility":313,"status":8,"city":314,"state":315,"zip":316,"country":286,"contacts":317,"geoPoint":319},"Ottawa Hospital Research Institute","Ottawa","Ontario","K1Y 4E9",[318],{"name":91,"role":92},{"lat":320,"lon":321},45.41117,-75.69812,[323],{"name":324,"role":92,"phone":325,"email":326},"Program Director","9196184721","snelson@baskingbiosciences.com",[328,331],{"name":329,"affiliation":282,"role":330},"Michael D Hill, MD","PRINCIPAL_INVESTIGATOR",{"name":332,"affiliation":333,"role":330},"Shahid M Nimjee, MD, PhD","Ohio State University",[],[],{"nct_id":4,"conditions":337,"biomarkers":339},[19,338],"Large Vessel Occlusion",[],{"nct_id":4,"found":15,"summary":341,"prompt_version":351},{"design":342,"status":343,"heading":344,"summary":345,"follow_up":346,"word_count":347,"commitments":348,"compensation":349,"drugs_mentioned":350},"This is a randomized, placebo-controlled, double-blinded study with two parts, aiming to enroll 228 participants. Participants will receive either BB-031 or a placebo.","completed","Study of BB-031 for Acute Ischemic Stroke","This study, called RAISE, is testing a new drug called BB-031 for people who have had an acute ischemic stroke. An ischemic stroke happens when a blood clot blocks blood flow to the brain. The study aims to see how safe BB-031 is and how well people tolerate it. You might be able to join if you are 18 or older, have had an acute ischemic stroke affecting the front part of your brain, and your symptoms started within 24 hours. You would receive either BB-031 or a placebo (an inactive substance like salt water). The main goal is to check for serious bleeding in the brain within 24 hours of treatment. The study plans to enroll 228 patients, but its current recruitment status is unclear.","Participants will be followed for 90 days after receiving treatment.",126,"You would be screened after a stroke diagnosis and then receive a single dose of the study drug or placebo. You would be followed for 90 days after treatment.","Not stated in the trial record.",[35,41],"v2"]