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

NCT05230758 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-01

No results posted yet for this 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?

Conditions

Interventions

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Donald Mabbott

    lead OTHER

Principal Investigators

  • Donald Mabbott, Ph.D. · The Hospital for Sick Children

  • Eric Bouffet, M.D. · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2027-11-30
Completion
2027-11-30

Countries

  • Australia
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230758 on ClinicalTrials.gov