Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-01 @ 10:41 AM
Study NCT ID:
NCT07055958
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients
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': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'motor aspects of daily living', 'timeFrame': '8 weeks', 'description': "motor aspects of daily living in MDS-UPDRS rating scale (Movement Disorder Society- sponsored revision of the Unified Parkinson's Disease Rating Scale). The score of Part 2 of this scale i.e. motor experiences of daily living is 13."}], 'secondaryOutcomes': [{'measure': '1. Plasma Malondealdehyde (MDA) level in micromole/litre. 2. Erythrocyte Glutathione (GSH) level in mg/ml.', 'timeFrame': '8 weeks', 'description': 'Malondealdehyde is oxidative stress marker. Glutathione is anti-oxidant.'}, {'measure': '1. Erythrocyte glutathione level in mg/ml 2. Erythrocyte Glutathione (GSH) level in mg/ml.', 'timeFrame': '8 weeks', 'description': 'Glutathione is an anti-oxidant Glutathione is anti-oxidant.'}, {'measure': 'Comparison of adverse effects in percentage', 'timeFrame': '8 weeks', 'description': 'Adverse effects in Metformin treated and placebo treated patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metformin, Parkinson disease'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn that metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson disease patients. Researcher will compare drug metformin to a placebo. Participants will take metformin or placebo for 8 weeks.', 'detailedDescription': "This clinical trial is an effort to explore whether administration of metformin has effect on motor aspects of daily living and oxidative stress in levodopa treated Parkinson's disease patients. After completion of necessary formalities, each participant will be assessed by translated and validated Bangla version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part questionnaire and malondialdehyde (MDA) and glutathione (GSH) will be measured at baseline and after 8 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed mild to moderate PD patients taking Levodopa\n* Age 18 years and older\n* Sex : Any\n\nExclusion Criteria:\n\n* Secondary causes of Parkinsonism\n* Prior stereotactic surgery for PD\n* Suffering from active malignancy\n* Known hypersensitivity to metformin\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT07055958', 'briefTitle': "Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients", 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': "Effect of Metformin as Add-on Therapy in Levodopa Treated Parkinson's Disease Patients: Randomized, Double Blind, Placebo Controlled Trial", 'orgStudyIdInfo': {'id': '5246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin- Patients receiving Levodopa with Metformin', 'description': 'Dosage form- Tab. Metformin 500 mg, Frequency - once daily, Duration - 8 weeks', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control - Patients receiving Levodopa with Placebo', 'description': 'placebo of Tab. Metformin 500 mg, frequency- once daily, duration- 8 weeks', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': "Metformin's chemical name is 1,1-Dimethylbiguanide, a molecular formula of C4H11N5. Beyond its well established antihyperglycemic impact, metformin demonstrated anti-oxidant and anti-inflammatory activities contributing its potential benefits in conditions associated with inflammation and oxidative stress. Furthermore, metformin rapidly crosses the blood brain barrier and disperses into several brain regions presenting an ideal therapeutic option for the treatment of PD.", 'armGroupLabels': ['Metformin- Patients receiving Levodopa with Metformin']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo of tab. Metformin of same shape', 'armGroupLabels': ['Control - Patients receiving Levodopa with Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1217', 'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'BSMMU', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'RUKHSANA AKTER', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}