OncoMatch/Clinical Trials/NCT05230758
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Is NCT05230758 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Metformin hydrochloride (HCl) 500mg tablet for medulloblastoma, childhood.
Treatment: Metformin hydrochloride (HCl) 500mg tablet — 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?
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: primary therapy
No less than 3 weeks after completion of: Primary therapy for: medulloblastoma OR ependymoma OR craniopharyngioma OR germ cell tumours OR any other brain tumour treated with cranial radiation - at the discretion of the Study PI OR Cranial radiation for relapsed ependymoma
Cannot have received: metformin (metformin hydrochloride)
Current use of metformin hydrochloride
Lab requirements
Kidney function
Estimated glomerular filtration rate (eGFR) > 75ml/min/1.73m² (calculated using the Schwartz formula: eGFR (mL/min/1.73m²) = (0.41 × height in cm) / creatinine in mg/dL)
Liver function
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)
Normal renal function defined as: Estimated glomerular filtration rate (eGFR) > 75ml/min/1.73m² ... Normal liver function defined as: SGOT (AST) ≤2.5 x institutional ULN for age and gender; 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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