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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.

Phase 3RecruitingDonald MabbottNCT05230758Data as of May 2026

Treatment: Metformin hydrochloride (HCl) 500mg tabletThe 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?

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Extracted eligibility criteria

Cancer type

Glioblastoma

Prior therapy

Min 1 prior line

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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