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Diabetes drug metformin tested to boost brain recovery in young cancer survivors

NCT ID NCT05230758

Symptom relief Sponsor: Donald Mabbott Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether metformin, a widely used diabetes drug, can improve memory and thinking in children and teens who have finished treatment for a brain tumor. About 140 participants aged 7 to 21 will take metformin or a placebo for 16 weeks. Researchers will measure changes in memory, processing speed, and brain growth using tests and brain scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin (a diabetes drug repurposed for brain recovery)
What this could lead to
If it works, this could offer a safe, affordable way to help children recover memory and thinking skills after brain tumor treatment.
What could go wrong
This is still a trial—metformin may not improve cognition more than placebo. The treatment is short (16 weeks), and long-term benefits are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

childhood germ cell tumor childhood medulloblastoma Cognitive Dysfunction craniopharyngioma ependymoma medulloblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive impairment Medulloblastoma, childhood

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alberta Children's Hospital

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • CHU Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • CHU de Québec - Université Laval

    RECRUITING

    Québec, Quebec, G1V 4G2, Canada

  • CHU de Sherbrooke

    RECRUITING

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Cancer Care Manitoba

    RECRUITING

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Children's & Women's Health Centre of British Columbia

    RECRUITING

    Vancouver, British Columbia, V6H 3V4, Canada

  • Children's Hospital in Westmead

    WITHDRAWN

    Westmead, New South Wales, 2145, Australia

  • Children's Hospital of Eastern Ontario

    RECRUITING

    Ottawa, Ontario, K1H 8L1, Canada

  • Children's Hospital, London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Hamilton Health Sciences - McMaster Children's Hospital

    RECRUITING

    Hamilton, Ontario, L8S 4K1, Canada

  • Izaak Walton Killam (IWK) Health Centre

    RECRUITING

    Halifax, Nova Scotia, B3K 6R8, Canada

  • John Hunter Children's Hospital

    RECRUITING

    New Lambton Heights, New South Wales, 2305, Australia

  • Monash Children's Hospital

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Montreal Children's Hospital

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Perth Children's Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Royal Children's Hospital

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Saskatchewan Health Authority

    RECRUITING

    Saskatoon, Saskatchewan, S7N 0W8, Canada

  • Stollery Children's Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Women and Childen's Hospital

    RECRUITING

    Adelaide, North Adelaide, SA 5006, Australia

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