Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-25 @ 3:17 PM
Study NCT ID:
NCT04121468
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2019-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multiple baseline'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2019-10-02', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events (safety and tolerability)', 'timeFrame': '3 years'}, {'measure': 'Number of patients who were approached to participate, declined participation and consented to participate (recruitment)', 'timeFrame': '3 years'}, {'measure': 'Proportion of patients who completed each visit within the trial (retention)', 'timeFrame': '3 years'}, {'measure': 'Proportion of patients who completed each of the outcome measures at the appropriate time points (adherence with outcome measures)', 'timeFrame': '3 years'}, {'measure': 'Number of patients enrolled in the study compared to the number of patients who were able to complete study measures (tolerability with outcome measures)', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Optical Coherence Tomography (OCT) - Retinal Nerve Fiber Layer Thickness', 'timeFrame': '3 years'}, {'measure': 'Optical Coherence Tomography (OCT) - Ganglion Cell Inner Plexiform Layer Thickness', 'timeFrame': '3 years'}, {'measure': 'Optical Coherence Tomography (OCT) - Optic Nerve Head Volume', 'timeFrame': '3 years'}, {'measure': 'Visual Evoked Potentials (VEP) - p100', 'timeFrame': '3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remyelination', 'youth', 'white matter', 'neural precursor cells', 'clinical trial', 'metformin'], 'conditions': ['Multiple Sclerosis (MS)']}, 'descriptionModule': {'briefSummary': 'A randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a history of MS with anterior visual pathway involvement and longer than 6 months after presentation with ON or an acute demyelinating event/relapse\n* Age 10 year to 25 years and 11 months\n* Latency delay \\> 115 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination) or \\> 10 milliseconds difference between eyes, or Retinal Nerve Fiber Layer (RNFL) thickness on OCT of \\< 90 µm in at least one eye or an inter-eye difference in the RNFL of 10 µm or more\n* Retinal Nerve Fiber Layer (RNFL) Thickness on baseline OCT ≥60 µm\n* If on an MS disease-modifying therapy, no changes in the therapeutic agent or dosing in the 6 months prior to study initiation\n* No significant renal or liver abnormalities\n* Expanded Disability Status Scale (EDSS) 0-6.0 (inclusive)\n* Has either English as his or her native language or English comprehension needed to complete the neuropsychological testing\n* Meet criteria for adequate organ function requirements as described below:\n\nAdequate renal function defined as:\n\nCreatinine clearance or radioisotope glomerular filtration rate (GFR) \\> 70 mL/min/1.73 m2 or serum creatinine based on age/gender as follows:\n\nRange Serum Creatinine Level (µmol/L): Age 5 to \\<12 years (male)=25-50, Age 5 to \\<12 years (female)=25-50; Age 12 to \\<15 years (male)=37-67, Age 12 to \\<15 years (female)=37-67; Age 15 to \\<19 years (male)=51-89, Age 15 to \\<19 years (female)=40-69; Age ≥19 years (male)=58-110; Age ≥19 years (female)=46-92\n\nAdequate liver function defined as:\n\nTotal bilirubin \\< 1.5 x upper limit of normal (ULN) for age SGOT (AST) or SGPT (ALT) \\< 1.5 x upper limit of normal (ULN) for age\n\nExclusion Criteria:\n\n* A history of retinal pathology (major ophthalmologic disease / concomitant ophthalmologic disorders)\n* Unstable and/or insulin-dependent (Type 1) diabetes, metabolic acidosis and/or lactic acidosis\n* History of unexplained hypoglycemia (\\<2.8 mmol/L)\n* Already on metformin\n* Concomitant use of any other putative remyelinating therapy as determined by the Principal/Qualified Investigator\n* Treatment for an acute attack with corticosteroids within 30 days prior to screening / relapse within 30 days prior to screening\n* Concomitant use of insulin\n* Concomitant use of any drugs that are listed to have drug-drug interactions with metformin (i.e. calcium channel blockers, diuretics, etc.) as determined by Principal/Qualified Investigator\n* Lactate levels \\> 1.5x upper limit of normal\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT04121468', 'briefTitle': 'A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '1000059119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A', 'description': 'Placebo for 3 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.\n\nMetformin for 9 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.', 'interventionNames': ['Drug: Metformin', 'Other: Placebo']}, {'type': 'OTHER', 'label': 'Group B', 'description': 'Placebo for 6 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.\n\nMetformin for 6 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.', 'interventionNames': ['Drug: Metformin', 'Other: Placebo']}, {'type': 'OTHER', 'label': 'Group C', 'description': 'Placebo for 9 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.\n\nMetformin for 3 months at dose of 500 mg/m2/day po (to be rounded) given in 1 or 2 divided doses for one week and if there are no side effects increased to 1000 mg/m2/day po given in 2 divided doses up to a maximum dose of 2000 mg/day.', 'interventionNames': ['Drug: Metformin', 'Other: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage'], 'description': 'Each tablet contains 500mg of metformin hydrochloride', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Each tablet contains no active drug ingredient', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brenna Wong', 'role': 'CONTACT', 'email': 'brenna.wong@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '415744'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'E. Ann Yeh, MA, MD, FRCPC, Dip ABPN', 'role': 'CONTACT', 'email': 'ann.yeh@sickkids.ca', 'phone': '416-813-7353'}, {'name': 'Brenna Wong', 'role': 'CONTACT', 'email': 'brenna.wong@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '415744'}], 'overallOfficials': [{'name': 'E. Ann Yeh, MA, MD, FRCPC, Dip ABPN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'collaborators': [{'name': "Queen's University", 'class': 'OTHER'}, {'name': 'Ontario Institute for Regenerative Medicine', 'class': 'UNKNOWN'}, {'name': 'Unity Health Toronto', 'class': 'OTHER'}, {'name': 'Stem Cell Network', 'class': 'OTHER'}, {'name': 'Multiple Sclerosis Society of Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Associate Scientist, Division of Neuroscience and Mental Health, SickKids Research Institute', 'investigatorFullName': 'E. Ann Yeh', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}