[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-traumatic-brain-injury-tbi\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-traumatic-brain-injury-tbi":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100605736","phase-2-valproic-acid-for-traumatic-brain-injury-trial-100605736",false,"NCT07166393","Valproic AcId for Traumatic BRAin INjury Trial","Multi-institutional Phase 2\u002F3 Trial of Valproic Acid in Patients With Moderate to Severe Traumatic Brain Injury","VIBRANT","Inclusion Criteria:\n\n1. Male or female between the ages of 18 and 65 years.\n2. Body Mass Index between 18 kg\u002Fm2 and 35 kg\u002Fm2.\n3. Females must be surgically sterilized, postmenopausal, or have a negative urine pregnancy test.\n4. Moderate to severe TBI: Glasgow Coma Scale (GCS) 3-12.\n5. Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG3) criteria\n\nExclusion Criteria:\n\n1. Persons with known history of adverse reactions to VPA\n2. Persons with known history of hepatitis B or C or clinical history of hepatic dysfunction, pancreatitis, or renal insufficiency.\n3. Persons with a known history of thrombocytopenia.\n4. Persons with platelet count less than 100,000 per microliter of blood.\n5. Persons with 2nd or 3rd degree burns of any size and location.\n6. Female subjects who are pregnant or lactating.\n7. Persons who are currently incarcerated or are in police custody.\n8. Persons with inadequate venous access.\n9. Treatment cannot start within 120 minutes from the onset of injury\n10. Non-survivable injuries in the estimation of the attending trauma surgeon.\n11. Interfacility transfers\n12. The time of injury is unknown\n13. Patients in hemorrhagic shock with a systolic blood pressure of \\\u003C90 mmHg on initial evaluation.\n14. Persons with a known \"do not resuscitate\" order prior to randomization\n15. Persons with a research \"opt out\" bracelet\n16. Persons who are currently enrolled in another clinical trial.\n17. Greater than 90 minutes between the onset of injury and arrival to the hospital","ALL","18 Years","65 Years",{"count":21,"type":22},432,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI).\n\nPatients with moderate to severe TBI will randomly receive either:\n\n1. Standard of care treatment and normal saline\n2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose",[29,30],"Moderate Traumatic Brain Injury (TBI)","Severe Traumatic Brain Injury",[32],"TBI, traumatic brain injury, VPA, valproic acid","NOT_YET_RECRUITING","2025-09-16",{"date":36,"type":37},"2025-09-22","ACTUAL",{"date":39,"type":22},"2026-05",{"date":41,"type":22},"2030-12",{"name":43,"class":44},"Northwestern University","OTHER",8,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100586356","phase-2-memantine-as-an-additive-therapy-in-patients-with-traumatic-brain-injury-100586356","NCT06914310","Memantine as an Additive Therapy in Patients With Traumatic Brain Injury","Inclusion Criteria:\n\n1. Patients between 18 and 70 years of age\n2. Patients mild (GCS 13-15) to moderate (GCS 9-12) TBI were assessed for the study eligibility.\n\nExclusion Criteria:\n\n1. Comorbid illnesses, such as diabetes mellitus, ischemic heart disease, acute myocardial infarction within the past 48 hours.\n2. Acute or chronic renal insufficiency.\n3. Hepatic diseases.\n4. Autoimmune diseases.\n5. Malignancies.\n6. Pregnancy.\n7. Patients unable to tolerate enteral feeding.\n8. More than 24 hours (h) since traumatic injury",{"count":53,"type":22},80,[25,26],"Memantine has shown promise in mitigating secondary brain injury in previous studies. One study demonstrated that early memantine administration in moderate TBI patients resulted in lower serum neuron-specific enolase levels and improved Glasgow Coma Scale scores. However, other trials investigating memantine's impact on long-term cognitive function in TBI patients have yielded mixed results. There is a need for well-controlled studies to determine the efficacy of memantine in improving neurological and cognitive outcomes in patients with TBI.",[57,29],"Mild Traumatic Brain Injury",[59,60,61],"Traumatic Brain Injury (TBI)","Memantine","S100β","2025-04-03",{"date":64,"type":37},"2025-04-06",{"date":66,"type":22},"2025-03-25",{"date":68,"type":22},"2025-11-30",{"name":70,"class":44},"Mansoura University",1]