Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05722951
Status:
COMPLETED
Last Update Posted:
2024-12-02
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin Efficacy and Safety in Epileptic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077287', 'term': 'Levetiracetam'}, {'id': 'D014635', 'term': 'Valproic Acid'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seizures Frequency', 'timeFrame': '6 months', 'description': 'will be recorded using seizures diary.'}, {'measure': 'Seizures Severity', 'timeFrame': '6 months', 'description': 'will be measured using chalfont seizures severity scale.'}, {'measure': 'Quality of Life level', 'timeFrame': '6 months', 'description': 'will be recorded using SF-36 health survey.'}], 'secondaryOutcomes': [{'measure': 'Change in BMI', 'timeFrame': '6 months'}, {'measure': 'Change in biological markers', 'timeFrame': '6 months', 'description': 'eg. serum lactate.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is:\n\n* Does metformin have beneficial effect on epileptic patients?\n* How metformin can affect epileptic patient's health?\n\nParticipants will be divided into 2 groups (control group and treatment group)\n\n* Control group will receive standard treatment (levetiracetam \\&/or sodium valproate).\n* Treatment group will receive standard treatment (levetiracetam \\&/or sodium valproate) + metformin"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 - 65 years old\n* Obese and overweight patients with body mass index (BMI) ≥ 25.\n* Diabetic \\& non diabetic patients.\n\nExclusion Criteria:\n\n* Patients with severe liver damage or kidney disease (eGFR below 45mL/min/1.73 m²).\n* Patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction).\n* Patients who are already taking metformin.\n* Cancer patients.\n* Pregnant or lactating women.\n* Patients with known hypersensitivity to the drug.'}, 'identificationModule': {'nctId': 'NCT05722951', 'briefTitle': 'Metformin Efficacy and Safety in Epileptic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Metformin Efficacy and Safety in Epileptic Patients', 'orgStudyIdInfo': {'id': '0107353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (+ve control)', 'description': 'levetiracetam \\&/or sodium valproate', 'interventionNames': ['Drug: Levetiracetam &/or sodium valproate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'metformin + (levetiracetam \\&/or sodium valproate)', 'interventionNames': ['Drug: Levetiracetam &/or sodium valproate', 'Drug: Metformin']}], 'interventions': [{'name': 'Levetiracetam &/or sodium valproate', 'type': 'DRUG', 'otherNames': ['Levetiracetam &/or valproic acid'], 'description': 'levetiracetam \\&/or sodium valproate will be given to 30 patients and monitored for 6 months', 'armGroupLabels': ['Control group (+ve control)', 'Treatment group']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'metformin + (levetiracetam \\&/or sodium valproate) will be given to 30 patients and monitored for 6 months will be given to 30 patients and monitored for 6 months', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Omnia Ashraf Abd El Aziz Ahmed Kotb', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teacher Assisstant', 'investigatorFullName': 'Omnia Ashraf Abd El Aziz Ahmed', 'investigatorAffiliation': 'Tanta University'}}}}