[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100371829":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":65,"collaborators":68,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":34,"eligibilityCriteria":84,"healthyVolunteers":81,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":34,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":51,"whyStopped":34,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14,18],{"label":9,"type":6,"description":10,"interventionNames":11},"Group A","Placebo for 3 months at dose of 500 mg\u002Fm2\u002Fday 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\u002Fm2\u002Fday po given in 2 divided doses up to a maximum dose of 2000 mg\u002Fday.\n\nMetformin for 9 months at dose of 500 mg\u002Fm2\u002Fday 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\u002Fm2\u002Fday po given in 2 divided doses up to a maximum dose of 2000 mg\u002Fday.",[12,13],"Drug: Metformin","Other: Placebo",{"label":15,"type":6,"description":16,"interventionNames":17},"Group B","Placebo for 6 months at dose of 500 mg\u002Fm2\u002Fday 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\u002Fm2\u002Fday po given in 2 divided doses up to a maximum dose of 2000 mg\u002Fday.\n\nMetformin for 6 months at dose of 500 mg\u002Fm2\u002Fday 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\u002Fm2\u002Fday po given in 2 divided doses up to a maximum dose of 2000 mg\u002Fday.",[12,13],{"label":19,"type":6,"description":20,"interventionNames":21},"Group C","Placebo for 9 months at dose of 500 mg\u002Fm2\u002Fday 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\u002Fm2\u002Fday po given in 2 divided doses up to a maximum dose of 2000 mg\u002Fday.\n\nMetformin for 3 months at dose of 500 mg\u002Fm2\u002Fday 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\u002Fm2\u002Fday po given in 2 divided doses up to a maximum dose of 2000 mg\u002Fday.",[12,13],[23,30],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Metformin","Each tablet contains 500mg of metformin hydrochloride",[9,15,19],[29],"Glucophage",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Placebo","Each tablet contains no active drug ingredient",[9,15,19],null,[36],{"name":37,"affiliation":5,"role":38},"E. Ann Yeh, MA, MD, FRCPC, Dip ABPN","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":34,"email":43},"CONTACT","416-813-7353","ann.yeh@sickkids.ca",{"name":45,"role":41,"phone":46,"phoneExt":47,"email":48},"Brenna Wong","416-813-7654","415744","brenna.wong@sickkids.ca",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Toronto","Ontario","M5G 1X8","Canada","CA",{"type":58,"coordinates":59},"Point",[60,61],-79.39864,43.70643,{"lat":61,"lon":60},[64],{"name":45,"role":41,"phone":46,"phoneExt":47,"email":48},{"type":38,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"E. Ann Yeh","Senior Associate Scientist, Division of Neuroscience and Mental Health, SickKids Research Institute",[69,71,73,75,77],{"name":70,"class":6},"Queen's University",{"name":72,"class":6},"Ontario Institute for Regenerative Medicine",{"name":74,"class":6},"Unity Health Toronto",{"name":76,"class":6},"Stem Cell Network",{"name":78,"class":6},"Multiple Sclerosis Society of Canada","100371829","phase-1-a-phase-i-double-blind-study-of-metformin-acting-on-endogenous-neural-progenitor-cells-in-children-and-young-adults-with-multiple-sclerosis-100371829",false,"NCT04121468","A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis","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\u002Frelapse\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 \\\u003C 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\u002Fmin\u002F1.73 m2 or serum creatinine based on age\u002Fgender as follows:\n\nRange Serum Creatinine Level (µmol\u002FL): Age 5 to \\\u003C12 years (male)=25-50, Age 5 to \\\u003C12 years (female)=25-50; Age 12 to \\\u003C15 years (male)=37-67, Age 12 to \\\u003C15 years (female)=37-67; Age 15 to \\\u003C19 years (male)=51-89, Age 15 to \\\u003C19 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 \\\u003C 1.5 x upper limit of normal (ULN) for age SGOT (AST) or SGPT (ALT) \\\u003C 1.5 x upper limit of normal (ULN) for age\n\nExclusion Criteria:\n\n* A history of retinal pathology (major ophthalmologic disease \u002F concomitant ophthalmologic disorders)\n* Unstable and\u002For insulin-dependent (Type 1) diabetes, metabolic acidosis and\u002For lactic acidosis\n* History of unexplained hypoglycemia (\\\u003C2.8 mmol\u002FL)\n* Already on metformin\n* Concomitant use of any other putative remyelinating therapy as determined by the Principal\u002FQualified Investigator\n* Treatment for an acute attack with corticosteroids within 30 days prior to screening \u002F 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\u002FQualified Investigator\n* Lactate levels \\> 1.5x upper limit of normal\n* Pregnancy","ALL","10 Years","25 Years",{"count":89,"type":90},20,"ESTIMATED","INTERVENTIONAL",[93,94],"PHASE1","PHASE2","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.",[97],"Multiple Sclerosis (MS)",[99,100,101,102,103,104],"remyelination","youth","white matter","neural precursor cells","clinical trial","metformin","2025-09-17",{"date":107,"type":108},"2025-09-23","ACTUAL",{"date":110,"type":108},"2020-02-24",{"date":112,"type":90},"2027-10",{"name":5,"class":6},1]