Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT07229651
Status:
RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metformin in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-13', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "change in The Unified Parkinson's Disease Rating Scale (UPDRS).", 'timeFrame': '6 months', 'description': "The unified Parkinson's disease rating scale is used to follow the longitudinal course of Parkinson's disease. The UPD rating scale is the most commonly used scale in the clinical study of Parkinson's disease."}], 'secondaryOutcomes': [{'measure': 'Change in PDQ-39', 'timeFrame': '6 months', 'description': "The Parkinson's Disease Questionnaire-39 (PDQ-39) is a widely recognized, disease-targeted, self-administered tool that captures patients' perspectives on how Parkinson's disease influences their health-related quality of life"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The clinical manifestations of Parkinson's disease (PD), a chronic neurodegenerative condition, include resting tremor, hypokinesia, bradykinesia, stiffness and postural instability. These motor symptoms are caused by a selective loss and degeneration of dopaminergic neurons in the substantia nigra pars compacta (SNpc) region, which leads to a dopamine (DA) insufficiency in the striatum"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEligible participants were men and women aged 50 years or older with a confirmed diagnosis of PD Patients receiving levodopa/carbidopa therapy.\n\nExclusion Criteria:\n\nSecondary causes of parkinsonism Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Cardiovascular disease patients Patients with coagulation disorders Suffering from active malignancy Addiction to alcohol and / or drugs Known allergy to the studied medications"}, 'identificationModule': {'nctId': 'NCT07229651', 'briefTitle': 'Metformin in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Safety and Efficacy of Metformin in Patients With Parkinson Disaese', 'orgStudyIdInfo': {'id': '4258'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Control group (Levo-dopa group, n =30) who will receive levodopa/carbidopa (125/12.5 mg) three times daily for 6 months', 'interventionNames': ['Drug: Levodopa Carbidopa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin group', 'description': 'Patients will receive levodopa/carbidopa (125/12.5 mg) three times daily plus metformin 500 mg two times daily for 6 months', 'interventionNames': ['Drug: Levodopa Carbidopa', 'Drug: Metformin']}], 'interventions': [{'name': 'Levodopa Carbidopa', 'type': 'DRUG', 'description': "Carbidopa/levodopa, also known as levocarb and co-careldopa, is the combination of the two medications carbidopa and levodopa. It is primarily used to manage the symptoms of Parkinson's disease", 'armGroupLabels': ['Control group', 'Metformin group']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin, sold under the brand name Glucophage, among others, is the main first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight.', 'armGroupLabels': ['Metformin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ihab Elsayed Hassan, MSC', 'role': 'CONTACT', 'email': 'ihassan@horus.edu.eg', 'phone': '01067831661'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ihab Elsayed Hassan', 'investigatorAffiliation': 'Tanta University'}}}}