[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586356":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":49,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":25,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":25,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":75,"whyStopped":25,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Memantine group","ACTIVE_COMPARATOR","Mild to moderate TBI patients will receive memantine. It will be given either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital and then continued for 3 weeks. The memantine dose in the first 7 days is 30 mg twice daily, while during the remaining 3 weeks the dose is 10 mg twice daily",[13],"Drug: Memantine",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","Mild to moderate TBI patients will be managed by mannitol or hypertonic saline to reduce brain swelling and analgesic for headache such as; acetaminophen.",[18],"Drug: Mannitol",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Memantine","Memantine will be given either orally or through a nasogastric tube for 7 days, starting on the first day of admission to the hospital and then continued for 3 weeks. The memantine dose in the first 7 days is 30 mg twice daily, while during the remaining 3 weeks the dose is 10 mg twice daily",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Mannitol","Mild to moderate TBI patients will receive mannitol in case of brain edema to reduce brain swelling and analgesic for headache such as; acetaminophen.",[15],[31],{"facility":5,"status":25,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Al Mansurah","Dakahlia Governorate","35516","Egypt","EG",{"type":38,"coordinates":39},"Point",[40,41],31.38069,31.03637,{"lat":41,"lon":40},[44],{"name":45,"role":46,"phone":47,"phoneExt":25,"email":48},"Shimaa Khaled Saber","CONTACT","01060383641","shimaa_khaled95@yahoo.com",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Noha Mansour","Associate professor","100586356","phase-2-memantine-as-an-additive-therapy-in-patients-with-traumatic-brain-injury-100586356",false,"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","ALL","18 Years",{"count":62,"type":63},80,"ESTIMATED","INTERVENTIONAL",[66,67],"PHASE2","PHASE3","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.",[70,71],"Mild Traumatic Brain Injury","Moderate Traumatic Brain Injury (TBI)",[73,22,74],"Traumatic Brain Injury (TBI)","S100β","NOT_YET_RECRUITING","2025-04-03",{"date":78,"type":79},"2025-04-06","ACTUAL",{"date":81,"type":63},"2025-03-25",{"date":83,"type":63},"2025-11-30",{"name":5,"class":6},1]