[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456989":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":40,"locations":47,"responsibleParty":365,"collaborators":66,"id":369,"slug":370,"hasResults":371,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":371,"sex":377,"minAge":378,"maxAge":379,"enrollmentInfo":380,"targetDuration":66,"studyType":383,"phases":384,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":50,"whyStopped":66,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","EXPERIMENTAL","Oral metformin will be administered approximately 500mg\u002Fm2\u002Fday for 1 week and increased to 1000mg\u002Fm2\u002Fday for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).",[13],"Drug: Metformin hydrochloride (HCl) 500mg tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Oral placebo will be administered approximately 500mg\u002Fm2\u002Fday for 1 week and increased to 1000mg\u002Fm2\u002Fday for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin hydrochloride (HCl) 500mg tablet","Metformin HCl 500mg tablets contain 500mg of active pharmaceutical ingredient (API) and are white, round, biconvex, film-coated tablets, with a score line on one face and debossed with \"HMR\" on the other. Each tablet contains the non-medicinal ingredients magnesium stearate and povidone. Tablet coating is comprised of hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide.",[9],[27],"Glucophage",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Matching white round tablet containing excipients only. The placebo tablets will match the active drug as closely as possible in terms of appearance.",[15],[32],"Control",[34,37],{"name":35,"affiliation":5,"role":36},"Donald Mabbott, Ph.D.","STUDY_CHAIR",{"name":38,"affiliation":5,"role":39},"Eric Bouffet, M.D.","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Lauren Cole, PhD","CONTACT","416-813-7396","307396","lauren.cole@sickkids.ca",[48,68,78,91,106,120,135,156,170,190,209,224,240,255,270,286,302,313,331,346],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"John Hunter Children's Hospital","RECRUITING","New Lambton Heights","New South Wales","2305","Australia","AU",{"type":57,"coordinates":58},"Point",[59,60],151.69364,-32.92466,{"lat":60,"lon":59},[63],{"name":64,"role":43,"phone":65,"phoneExt":66,"email":67},"Frank Alvaro, MMBS","+612 4985 5612",null,"frank.alvaro@health.nsw.gov.au",{"facility":69,"status":70,"city":71,"state":52,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":66},"Children's Hospital in Westmead","WITHDRAWN","Westmead","2145",{"type":57,"coordinates":74},[75,76],150.98768,-33.80383,{"lat":76,"lon":75},{"facility":79,"status":50,"city":80,"state":81,"zip":82,"country":54,"countryCode":55,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Women and Childen's Hospital","Adelaide","North Adelaide","SA 5006",{"type":57,"coordinates":84},[85,86],138.59863,-34.92866,{"lat":86,"lon":85},[89],{"name":90,"role":43,"phone":66,"phoneExt":66,"email":66},"Jordan Hansford, Ph.D.",{"facility":92,"status":50,"city":93,"state":94,"zip":95,"country":54,"countryCode":55,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Monash Children's Hospital","Clayton","Victoria","3168",{"type":57,"coordinates":97},[98,99],145.11667,-37.91667,{"lat":99,"lon":98},[102],{"name":103,"role":43,"phone":104,"phoneExt":66,"email":105},"Peter Downie, MBBS","+613 8572 3456","Peter.Downie@monashhealth.org",{"facility":107,"status":50,"city":108,"state":94,"zip":109,"country":54,"countryCode":55,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Royal Children's Hospital","Parkville","3052",{"type":57,"coordinates":111},[112,113],144.95,-37.78333,{"lat":113,"lon":112},[116],{"name":117,"role":43,"phone":118,"phoneExt":66,"email":119},"Molly Williams, MBBS","+613 9345 9184","molly.wiliams@rch.org.au",{"facility":121,"status":50,"city":122,"state":123,"zip":124,"country":54,"countryCode":55,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Perth Children's Hospital","Nedlands","Western Australia","6009",{"type":57,"coordinates":126},[127,128],115.8073,-31.98184,{"lat":128,"lon":127},[131],{"name":132,"role":43,"phone":133,"phoneExt":66,"email":134},"Santosh Valvi, MBBS","+618 6456 3612","santosh.valvi@health.wa.gov.au",{"facility":136,"status":50,"city":137,"state":138,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Alberta Children's Hospital","Calgary","Alberta","T3B 6A8","Canada","CA",{"type":57,"coordinates":143},[144,145],-114.08529,51.05011,{"lat":145,"lon":144},[148,152],{"name":149,"role":43,"phone":150,"phoneExt":66,"email":151},"Lucie Lafay-Cousin, MD","403-955-2554","lucie.lafay-cousin@albertahealthservices.ca",{"name":153,"role":43,"phone":154,"phoneExt":66,"email":155},"Sherry Qian","403-955-7263","Sherry.Qian@AlbertaHealthServices.ca",{"facility":157,"status":50,"city":158,"state":138,"zip":159,"country":140,"countryCode":141,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Stollery Children's Hospital","Edmonton","T6G 2B7",{"type":57,"coordinates":161},[162,163],-113.46871,53.55014,{"lat":163,"lon":162},[166],{"name":167,"role":43,"phone":168,"phoneExt":66,"email":169},"Liana Nobre, MD","780-407-8798","Liana.Nobre@albertahealthservices.ca",{"facility":171,"status":50,"city":172,"state":173,"zip":174,"country":140,"countryCode":141,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Children's & Women's Health Centre of British Columbia","Vancouver","British Columbia","V6H 3V4",{"type":57,"coordinates":176},[177,178],-123.11934,49.24966,{"lat":178,"lon":177},[181,185],{"name":182,"role":43,"phone":183,"phoneExt":66,"email":184},"Sylvia Cheng, MD","604-875-2406","Sylvia.Cheng@cw.bc.ca",{"name":186,"role":43,"phone":187,"phoneExt":188,"email":189},"Alecia Lim","604-875-2345","5262","CRA@cw.bc.ca",{"facility":191,"status":50,"city":192,"state":193,"zip":194,"country":140,"countryCode":141,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Cancer Care Manitoba","Winnipeg","Manitoba","R3E 0V9",{"type":57,"coordinates":196},[197,198],-97.14704,49.8844,{"lat":198,"lon":197},[201,205],{"name":202,"role":43,"phone":203,"phoneExt":66,"email":204},"Magimairajan I Vanan, MD","204-787-4724","mivanan@cancercare.mb.ca",{"name":206,"role":43,"phone":207,"phoneExt":66,"email":208},"Clinical Trial Unit CTU","204-787-4156","ctu_web@cancercare.mb.ca",{"facility":210,"status":50,"city":211,"state":212,"zip":213,"country":140,"countryCode":141,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Izaak Walton Killam (IWK) Health Centre","Halifax","Nova Scotia","B3K 6R8",{"type":57,"coordinates":215},[216,217],-63.57688,44.64269,{"lat":217,"lon":216},[220],{"name":221,"role":43,"phone":222,"phoneExt":66,"email":223},"Craig Erker, MD","902-470-3743","craig.erker@iwk.nshealth.ca",{"facility":225,"status":50,"city":226,"state":227,"zip":228,"country":140,"countryCode":141,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Hamilton Health Sciences - McMaster Children's Hospital","Hamilton","Ontario","L8S 4K1",{"type":57,"coordinates":230},[231,232],-79.84963,43.25011,{"lat":232,"lon":231},[235],{"name":236,"role":43,"phone":237,"phoneExt":238,"email":239},"Adam Fleming, MD","905-521-2100","76720","afleming@mcmaster.ca",{"facility":241,"status":50,"city":242,"state":227,"zip":243,"country":140,"countryCode":141,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Children's Hospital, London Health Sciences Centre","London","N6A 5W9",{"type":57,"coordinates":245},[246,247],-81.23304,42.98339,{"lat":247,"lon":246},[250],{"name":251,"role":43,"phone":252,"phoneExt":253,"email":254},"Shayna Zelcer, MD","519-685-8500","52678","Shayna.Zelcer@lhsc.on.ca",{"facility":256,"status":50,"city":257,"state":227,"zip":258,"country":140,"countryCode":141,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"Children's Hospital of Eastern Ontario","Ottawa","K1H 8L1",{"type":57,"coordinates":260},[261,262],-75.69812,45.41117,{"lat":262,"lon":261},[265],{"name":266,"role":43,"phone":267,"phoneExt":268,"email":269},"Donna Johnston, MD","613-737-7600","2210","djohnston@cheo.on.ca",{"facility":5,"status":50,"city":271,"state":227,"zip":272,"country":140,"countryCode":141,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"Toronto","M5G 1X8",{"type":57,"coordinates":274},[275,276],-79.39864,43.70643,{"lat":276,"lon":275},[279,284],{"name":280,"role":43,"phone":281,"phoneExt":282,"email":283},"Vijay Ramaswamy, MD","416-813-7654","208221","vijay.ramaswamy@sickkids.ca",{"name":42,"role":43,"phone":44,"phoneExt":45,"email":285},"cynthia.demedeiros@sickkids.ca",{"facility":287,"status":50,"city":288,"state":289,"zip":290,"country":140,"countryCode":141,"cosmosGeoPoint":291,"geoPoint":295,"contacts":296},"CHU Sainte-Justine","Montreal","Quebec","H3T 1C5",{"type":57,"coordinates":292},[293,294],-73.58781,45.50884,{"lat":294,"lon":293},[297],{"name":298,"role":43,"phone":299,"phoneExt":300,"email":301},"Sébastien Perreault, MD","514-345-4931","5019","s.perreault@umontreal.ca",{"facility":303,"status":50,"city":288,"state":289,"zip":304,"country":140,"countryCode":141,"cosmosGeoPoint":305,"geoPoint":307,"contacts":308},"Montreal Children's Hospital","H4A 3J1",{"type":57,"coordinates":306},[293,294],{"lat":294,"lon":293},[309],{"name":310,"role":43,"phone":311,"phoneExt":66,"email":312},"Geneviève Legault, MD","514-412-4445","genevieve.legault4@mcgill.ca",{"facility":314,"status":50,"city":315,"state":289,"zip":316,"country":140,"countryCode":141,"cosmosGeoPoint":317,"geoPoint":321,"contacts":322},"CHU de Québec - Université Laval","Québec","G1V 4G2",{"type":57,"coordinates":318},[319,320],-71.21454,46.81228,{"lat":320,"lon":319},[323,328],{"name":324,"role":43,"phone":325,"phoneExt":326,"email":327},"Samuele Renzi, MD","418-525-4444","40121","samuele.renzi.med@ssss.gouv.qc.ca",{"name":329,"role":43,"phone":66,"phoneExt":66,"email":330},"General Contact","recherche.onco.ped@crchudequebec.ulaval.ca",{"facility":332,"status":50,"city":333,"state":289,"zip":334,"country":140,"countryCode":141,"cosmosGeoPoint":335,"geoPoint":339,"contacts":340},"CHU de Sherbrooke","Sherbrooke","J1G 2E8",{"type":57,"coordinates":336},[337,338],-71.89908,45.40008,{"lat":338,"lon":337},[341],{"name":342,"role":43,"phone":343,"phoneExt":344,"email":345},"Stéphanie Vairy, MD","819-346-1110","7-3068","Stephanie.Vairy@USherbrooke.ca",{"facility":347,"status":50,"city":348,"state":349,"zip":350,"country":140,"countryCode":141,"cosmosGeoPoint":351,"geoPoint":355,"contacts":356},"Saskatchewan Health Authority","Saskatoon","Saskatchewan","S7N 0W8",{"type":57,"coordinates":352},[353,354],-106.66892,52.13238,{"lat":354,"lon":353},[357,361],{"name":358,"role":43,"phone":359,"phoneExt":66,"email":360},"Kathleen Felton, MD","306-655-2733","Kathleen.Felton@saskhealthauthority.ca",{"name":362,"role":43,"phone":363,"phoneExt":66,"email":364},"Jessica Marien","306-655-3544","Jessica.Marien@saskhealthauthority.ca",{"type":366,"investigatorFullName":367,"investigatorTitle":368,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"SPONSOR_INVESTIGATOR","Donald Mabbott","Psychologist","100456989","phase-3-effect-of-metformin-on-behaviour-and-the-brain-in-children-treated-for-a-brain-tumour-100456989",false,"NCT05230758","Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour","Phase III Randomized Double-blind Placebo-controlled Trial of Metformin for Cognitive Recovery and White Matter Growth in Paediatric Patients With a Brain Tumour","Met Med Can","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. No less than 3 weeks after completion of:\n\n   * Primary therapy for:\n\n     1. medulloblastoma\n\n        OR\n     2. ependymoma\n\n        OR\n     3. craniopharyngioma\n\n        OR\n     4. germ cell tumours\n\n        OR\n   * Primary therapy for any other brain tumour treated with cranial radiation - at the discretion of the Study PI\n\n   OR\n   * Cranial radiation for relapsed ependymoma\n2. Age 7 years to 21 years and 11 months at the time of enrollment\n3. Either declare English (or French in accepting sites) as their native language or have had at least two years of schooling in English (or French in accepting sites) at the time of consent\n4. Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen\n5. Meet criteria for normal organ function requirements as described below:\n\n   1. Normal renal function defined as: Estimated glomerular filtration rate (eGFR) \\> 75ml\u002Fmin\u002F1.73m²\n\n      * eGFR is calculated using the Schwartz formula: eGFR (mL\u002Fmin\u002F1.73m²) = (0.41 × height in cm) \u002F creatinine in mg\u002FdL\n   2. Normal liver function defined as:\n\n      * Serum glutamic-oxaloacetic transaminase (SGOT) (AST) ≤2.5 x institutional upper limit of normal (ULN) for age and gender\n      * Serum glutamic pyruvic transaminase (SGPT) (ALT) ≤2.5 x institutional ULN for age and gender\n      * Total bilirubin \\\u003C1.5x institutional ULN for age and gender (patients with documented Gilbert's Disease may be enrolled with Sponsor approval and total bilirubin ≤2.0 x institutional ULN)\n6. Informed consent (and assent, where applicable) will be obtained from the participants and\u002For their legal guardian(s) by study team members delegated to consent for this study\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will not be eligible to take part in the trial:\n\n1. Standard score of less than 60 for full scale IQ on the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) (or other Wechsler Scale of Intelligence for English speaking participants) or pro-rated IQ score on the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) for French speaking participants at Screening visit\n2. Have a known hypersensitivity to metformin hydrochloride\n3. Have unstable and\u002For insulin-dependent (Type 1) diabetes\n4. Have a history of hypoglycemia after 2 years of age\n5. Have been diagnosed with acute or chronic metabolic acidosis and\u002For lactic acidosis or if bicarbonate (Total CO2) is less than 22 mmol\u002FL at the Screening visit\n6. Have a history of renal disease or renal dysfunction pre-existing to the diagnosis of Medulloblastoma\n7. Have a history of congestive heart failure requiring pharmacologic treatment (including the use of diuretics) within two years prior to study entry\n8. Currently taking part in a cognitive rehabilitation intervention study\n9. Treatment or planned treatment involving diuretics\n10. Current or planned treatment with cationic drugs excreted by the kidneys (e.g. amiloride, cimetidine, digoxin, morphine, nifedipine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin)\n11. Current or planned treatment with concomitant medications with potential unacceptable interaction with metformin including, lamotrigine, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, glycopyrrolate, and carbonic anhydrase inhibitors, or at the discretion of the Site PI or delegate for medications with potential interactions such as sertraline, lansoprazole and omeprazole.\n12. Pernicious anemia (according to results of the Screening visit blood draw)\n13. Current use of metformin hydrochloride\n14. Any condition or diagnosis, that could in the opinion of the Site PI or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk\n15. Are receiving palliative care","ALL","7 Years","21 Years",{"count":381,"type":382},140,"ESTIMATED","INTERVENTIONAL",[385],"PHASE3","The efficacy of treatment with metformin for promoting cognitive recovery and brain growth in children\u002Fadolescents treated for a brain tumour will be investigated in a multi-site Phase III randomized double-blind placebo-controlled parallel arm superiority trial. Specifically, in children\u002Fadolescents aged 7 years to 21 years and 11 months who have completed treatment for a brain tumour, is oral administration of metformin for 16 weeks associated with greater improvement of cognitive function and brain growth compared to placebo administered for 16 weeks?",[388,389],"Medulloblastoma, Childhood","Cognitive Impairment",[9,391,392,393],"Paediatric brain tumour","Memory","Cognitive late effects","2026-04-27",{"date":396,"type":397},"2026-05-01","ACTUAL",{"date":399,"type":397},"2022-07-01",{"date":401,"type":382},"2027-11-30",{"name":367,"class":6},20]