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Clinical Trials in Australia / NCT05230758
Recruiting Phase 3

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour

NCT05230758 · tracked via the Priya Life Science Australia tracker
Sponsor
Donald Mabbott
Phase
Phase 3
Started
2022-07-01
Last updated
2026-09-24

Condition(s) studied

Medulloblastoma, ChildhoodCognitive Impairment

Investigational drug(s) / intervention(s)

Metformin hydrochloride (HCl) 500mg tablet →Placebo

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.

Placebo: Matching white round tablet containing excipients only. The placebo tablets will match the active drug as closely as possible in terms of appearance.

Study summary

The efficacy of treatment with metformin for promoting cognitive recovery and brain growth in children/adolescents 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/adolescents 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?

Eligibility

Sex
ALL
Min age
7 Years
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. No less than 3 weeks after completion of: * Primary therapy for: 1. medulloblastoma OR 2. ependymoma OR 3. craniopharyngioma OR 4. germ cell tumours OR * Primary therapy for any other brain tumour treated with cranial radiation - at the discretion of the Study PI OR * Cranial radiation for relapsed ependymoma 2. Age 7 years to 21 years and 11 months at the time of enrollment 3. 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 4. Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen 5. Meet criteria for normal organ function requirements as described below: 1. Normal renal function defined as: Estimated glomerular filtration rate (eGFR) \> 75ml/min/1.73m² * eGFR is calculated using the Schwartz formula: eGFR (mL/min/1.73m²) = (0.41 × height in cm) / creatinine in mg/dL 2. Normal liver function defined as: * Serum glutamic-oxaloacetic transaminase (SGOT) (AST) ≤2.5 x institutional upper limit of normal (ULN) for age and gender * Serum glutamic pyruvic transaminase (SGPT) (ALT) ≤2.5 x institutional ULN for age and gender * Total bilirubin \<1.5x 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) 6. Informed consent (and assent, where applicable) will be obtained from the participants and/or their legal guardian(s) by study team members delegated to consent for this study Exclusion Criteria: Participants who meet any of the following criteria will not be eligible to take part in the trial: 1. 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 2. Have a known hypersensitivity to metformin hydrochloride 3. Have unstable and/or insulin-dependent (Type 1) diabetes 4. Have a history of hypoglycemia after 2 years of age 5. Have been diagnosed with acute or chronic metabolic acidosis and/or lactic acidosis or if bicarbonate (Total CO2) is less than 22 mmol/L at the Screening visit 6. Have a history of renal disease or renal dysfunction pre-existing to the diagnosis of Medulloblastoma 7. Have a history of congestive heart failure requiring pharmacologic treatment (including the use of diuretics) within two years prior to study entry 8. Currently taking part in a cognitive rehabilitation intervention study 9. Treatment or planned treatment involving diuretics 10. 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) 11. 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. 12. Pernicious anemia (according to results of the Screening visit blood draw) 13. Current use of metformin hydrochloride 14. 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 15. Are receiving palliative care

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
John Hunter Children's Hospital New Lambton Heights New South Wales Recruiting
Children's Hospital in Westmead Westmead New South Wales Withdrawn
Women and Childen's Hospital Adelaide North Adelaide Recruiting
Monash Children's Hospital Clayton Victoria Recruiting
Royal Children's Hospital Parkville Victoria Recruiting
Perth Children's Hospital Nedlands Western Australia Recruiting
Alberta Children's Hospital Calgary Alberta Recruiting
Stollery Children's Hospital Edmonton Alberta Recruiting
Children's & Women's Health Centre of British Columbia Vancouver British Columbia Recruiting
Cancer Care Manitoba Winnipeg Manitoba Recruiting
Izaak Walton Killam (IWK) Health Centre Halifax Nova Scotia Recruiting
Hamilton Health Sciences - McMaster Children's Hospital Hamilton Ontario Recruiting
Children's Hospital, London Health Sciences Centre London Ontario Recruiting
Children's Hospital of Eastern Ontario Ottawa Ontario Recruiting
The Hospital for Sick Children Toronto Ontario Recruiting
CHU Sainte-Justine Montreal Quebec Recruiting
Montreal Children's Hospital Montreal Quebec Recruiting
CHU de Québec - Université Laval Québec Quebec Recruiting
CHU de Sherbrooke Sherbrooke Quebec Recruiting
Saskatchewan Health Authority Saskatoon Saskatchewan Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05230758 on ClinicalTrials.gov ↗ ← All trials in Australia