[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613928":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":42,"responsibleParty":59,"collaborators":31,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":31,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":31,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":87,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Badr University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","ACTIVE_COMPARATOR","The metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily",[13],"Drug: Metformin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily",[9],[26],"Glucophage 1000 mg tablets",{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":29},[15],[30],"Metformin free tablets",null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Eman Swan, PHD","CONTACT","+201090111013","eman.said@buc.edu.eg",{"name":39,"role":35,"phone":40,"phoneExt":31,"email":41},"Saeed Alemam, PHD","+201027345368","Said.elemam@med.menofia.edu.eg",[43],{"facility":44,"status":31,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Neurosurgery department at Menoufia University hospitals at Menoufia University.","Shibīn al Kawm","Menoufia","32817","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],31.00904,30.55258,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":40,"phoneExt":31,"email":41},"Said Elemam, PHD",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Eman Said Sawan","Lecturer of Clinical Pharmacy, Faculty of Pharmacy","100613928","phase-4-metformin-in-preventing-secondary-gliosis-following-acute-thoraco-lumbar-spinal-cord-injury-100613928",false,"NCT07272967","Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury","Safety and Efficacy of Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury: A Randomized, Double-Blinded, Placebo-Controlled Study.","Inclusion Criteria:\n\n* Adults aged 18-65 years, who had acute, non-penetrating thoraco-lumbar SCI (T1-conus medullaris), with new neurological deficits.\n* Injury occurred within the past 24 hours before enrollment.\n* American Spinal Injury Association (ASIA) Impairment Scale grade B-D.\n* Able to undergo MRI of the spine.\n* Informed consent provided by patient or legal representative.\n\nExclusion Criteria:\n\n* Major spinal transaction or cervical spinal cord injury.\n* Prior spinal surgery or pre-existing spinal pathology (e.g., kyphosis, tumors).\n* Concomitant severe traumatic brain injury (Glasgow Coma Scale \\\u003C 13) or other CNS injury that would confound neurological assessment.\n* Known diabetes mellitus (type 1 or 2) or current use of metformin.\n* Penetrating spinal injury (e.g. gunshot, stab wound).\n* Implanted metallic devices or conditions precluding MRI.\n* Pregnancy or breastfeeding.\n* Severe comorbidities (e.g. end-stage liver disease, renal failure with eGFR\\\u003C30 mL\u002Fmin).\n* Known allergy to metformin.\n* Uncontrolled infection or sepsis at presentation.","ALL","18 Years","65 Years",{"count":74,"type":75},34,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","Background:\n\nSpinal cord injury (SCI) is a major global health problem, with thoraco-lumbar injuries often leading to paraplegia and incomplete neurological recovery. The glial scar, resulting from astrocyte activation at the injury site, constitutes a major barrier to axon regeneration. Given the limitations of current treatments, there is an urgent need for new interventions to improve outcomes. Metformin, a common drug for diabetes, shows promising potential as a neuroprotective agent in preclinical SCI models, where it improves motor function and reduces pain and glial scar formation. Its safety in acute neurological injury has also been supported in a recent human trial for severe traumatic brain injury.\n\nObjective:\n\nTo test the safety and efficacy of metformin in acute thoraco-lumbar SCI, focusing on neurological and functional outcomes as well as DTI metrics of spinal cord integrity.\n\nMethods. Study Design. Randomized, double-blinded, placebo-controlled study.\n\nPopulation:\n\nParticipants that will be admitted during the time of the study to Neurosurgery department at Menoufia University hospitals at Menoufia University.\n\nSetting:\n\nNeurosurgery department at Menoufia University hospitals at Menoufia University.\n\nKeywords:\n\nMetformin, spinal cord injury, gliosis, randomized controlled trial, neuroprotection",[81],"Spinal Cord Injury (SCI)",[9,83,84,85,86],"spinal cord injury,","gliosis",", randomized controlled trial","neuroprotection","NOT_YET_RECRUITING","2025-11-26",{"date":90,"type":91},"2025-12-09","ACTUAL",{"date":93,"type":75},"2026-01-01",{"date":95,"type":75},"2026-02-01",{"name":5,"class":6},1]