Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07272967
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D005911', 'term': 'Gliosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-19', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neurological recovery', 'timeFrame': '2 weeks, and 3-months postoperatively.', 'description': 'Comparison of postoperative American Spinal Injury Association (ASIA) Impairment Scale grade ranging from A to E where Grade A= Complete spinal cord injury and Grade E=Normal function'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'at 2 weeks, and 3-months postoperatively', 'description': 'Comparison of postoperative patient-reported pain using Visual Analog Scale (VAS) that is ranging from 0-10 score where 0=no pain and10= the worst possible pain'}, {'measure': 'Neuropathic Pain character', 'timeFrame': 'at 2 weeks, and 3-months postoperatively', 'description': 'Comparison of postoperative Neuropathic character of pain using Neuropathic Pain Symptom Inventory (NPSI) scale ranging from 0-10 score where 0=no pain and 10= the worst possible pain'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin', 'spinal cord injury,', 'gliosis', ', randomized controlled trial', 'neuroprotection'], 'conditions': ['Spinal Cord Injury (SCI)']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': 'Study Design. Randomized, double-blinded, placebo-controlled study. Randomization and Blinding. Participants will be randomly assigned to either the metformin or placebo group in a 1:1 ratio using block randomization. A computer-generated randomization sequence will be created with the R software (version 4.4.1) and the blockrand package(7). This sequence will be securely stored and accessible only to the study statistician. Treatment packets will be pre-labeled with unique numbers matching the randomization sequence. When a patient qualifies for the study, they will receive a numbered packet corresponding to their assignment. To ensure objectivity, neither participants nor study staff will know which number corresponds to metformin or placebo-only the statistician will have access to this information.\n\nSetting:\n\nNeurosurgery department at Menoufia University hospitals at Menoufia University.\n\nInstruments:\n\nWe will assess the patient using AISA grade, Visual Analog Scale (VAS) and the Neuropathic Pain Symptom Inventory (NPSI) (8-10).\n\nData collection:\n\nIt will be done by data collaborators under the leadership of the investigators in: Neurosurgery department at Menoufia University hospitals at Menoufia University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\< 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\\<30 mL/min).\n* Known allergy to metformin.\n* Uncontrolled infection or sepsis at presentation.'}, 'identificationModule': {'nctId': 'NCT07272967', 'briefTitle': 'Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Badr University'}, 'officialTitle': 'Safety and Efficacy of Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury: A Randomized, Double-Blinded, Placebo-Controlled Study.', 'orgStudyIdInfo': {'id': '9/2025NEUS6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin', 'description': 'The metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage 1000 mg tablets'], 'description': 'Participants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily', 'armGroupLabels': ['Metformin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Metformin free tablets'], 'description': 'Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32817', 'city': 'Shibīn al Kawm', 'state': 'Menoufia', 'country': 'Egypt', 'contacts': [{'name': 'Said Elemam, PHD', 'role': 'CONTACT', 'email': 'Said.elemam@med.menofia.edu.eg', 'phone': '+201027345368'}], 'facility': 'Neurosurgery department at Menoufia University hospitals at Menoufia University.', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}], 'centralContacts': [{'name': 'Eman Swan, PHD', 'role': 'CONTACT', 'email': 'eman.said@buc.edu.eg', 'phone': '+201090111013'}, {'name': 'Saeed Alemam, PHD', 'role': 'CONTACT', 'email': 'Said.elemam@med.menofia.edu.eg', 'phone': '+201027345368'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data is available with corresponding author on reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badr University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy, Faculty of Pharmacy', 'investigatorFullName': 'Eman Said Sawan', 'investigatorAffiliation': 'Badr University'}}}}