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 (Jun 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
Treatments studied
Other
Cancer type
Glioblastoma
Demographics
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.
Frequently asked questions
Is NCT05230758 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior metformin disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger and at least 7 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages