[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650025":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":45,"locations":34,"responsibleParty":55,"collaborators":34,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":34,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":81,"whyStopped":34,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":34},{"fullName":5,"class":6},"NeuroTrauma Sciences, LLC","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo 0.9% saline solution","PLACEBO_COMPARATOR","0.9% saline solution",[13],"Other: Placebo Control",{"label":15,"type":16,"description":17,"interventionNames":18},"Low Dose NTS-521","EXPERIMENTAL","Low Dose NTS-521 in 0.9% saline delivered IV",[19],"Drug: NTS-521",{"label":21,"type":16,"description":22,"interventionNames":23},"Medium Dose NTS-521","Medium Dose NTS-521 in 0.9% saline delivered IV",[19],{"label":25,"type":16,"description":26,"interventionNames":27},"High Dose NTS-521","High Dose NTS-521 in 0.9% saline delivered IV",[19],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","NTS-521","Intravenous NTS-521",[25,15,21],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"OTHER","Placebo Control","0.9% saline solution delivered intravenously",[9],[41],{"name":42,"affiliation":43,"role":44},"Bijoy A Menon, MD","The University of Calgary Stroke Program & Stroke Clinical Trial Group","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":34,"email":50},"Scott C Oshana, BS","CONTACT","18603022074","s.oshana@neurotraumasciences.com",{"name":52,"role":48,"phone":53,"phoneExt":34,"email":54},"Allison Ward, MSA, MSEd","910-616-8586","a.ward@neurotraumasciences.com",{"type":56,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100650025","phase-2-a-phase-2a-study-to-evaluate-the-dose-response-safety-tolerability-efficacy-and-population-pharmacokinetics-of-intravenous-nts-521-infusions-in-the-early-recovery-treatment-from-acute-ischemic-stroke-100650025",false,"NCT07742098","A Phase 2a Study to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke","A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Domain Within the ACT-GLOBAL Trial Platform, to Evaluate the Dose-response, Safety, Tolerability, Efficacy, and Population Pharmacokinetics of Intravenous NTS-521 Infusions in the Early Recovery Treatment From Acute Ischemic Stroke","ACT-IVATE","Inclusion Criteria:\n\n* Acute ischemic stroke with moderate to severe hemiparesis\n* Functional independence in activities of daily living without requiring nursing care before the index stroke.\n* Consent process by participant or proxy, with reconsent provision.\n* Age ≥ 45 to ≤ 80 years of age (inclusive) on the date of randomization\n* Sufficient attention, comprehension, and cooperation to carry out instructions\n\nExclusion Criteria:\n\n* Pre-existing motor deficit prior to index stroke\n* Posterior circulation ischemic stroke\n* Lacunar stroke\n* Qualifying brain imaging demonstrating intracranial hemorrhage, malignant middle cerebral artery (MCA) infarct with edema, or bilateral\u002Fmultifocal infarcts, clinically significant vascular malformation, brain tumor, or other central nervous system (CNS) pathology\n* Recent major surgery or trauma (\\\u003C30 days)","ALL","45 Years","80 Years",{"count":69,"type":70},140,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This is a trial to evaluate the safety and effect of three intravenous (IV) doses of NTS-521 for the early recovery treatment of acute ischemic stroke (AIS). Participants will be followed for 90 days.",[76],"Acute Ischemic Stroke",[76,78,79,80],"AIS","Ischemic Stroke","Stroke","NOT_YET_RECRUITING","2026-07-31",{"date":84,"type":85},"2026-08-03","ACTUAL",{"date":87,"type":70},"2026-10-31",{"date":89,"type":70},"2028-12-15",{"name":5,"class":6}]