Phase 3 Brain Cancer Trial, RecruitingNCT05230758Sponsor: Donald MabbottCondition: Brain Cancer
Printed from Voxsanity (voxsanity.com.au) — NCT05230758 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
AI generated eligibility summary.
Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source.
How we use AI
Who might be able to join this trial:
People who finished primary treatment for medulloblastoma, ependymoma, craniopharyngioma, germ cell tumours, another brain tumour treated with radiation to the head, or radiation for relapsed ependymoma — and at least 3 weeks have passed since that treatment ended.
People aged 7 years to 21 years and 11 months at the time of joining the study.
People whose native language is English (or French at sites that accept French speakers), or who have had at least two years of schooling in English (or French at accepting sites).
People who are able to swallow tablets whole, crushed, or through a feeding tube, and are willing to follow the study medication schedule.
People whose kidneys are working well enough, as measured by a standard calculation using height and a blood test result (confirm with trial site for exact threshold).
People whose liver is functioning within acceptable ranges, based on specific blood test results (confirm with trial site for exact values).
People (or their parent or legal guardian, where applicable) who are willing and able to provide informed consent to participate.
Who may not be able to join:
People whose IQ score on a specific intelligence test falls below 60 at the screening visit.
People who have a known allergy or sensitivity to metformin hydrochloride (the study drug).
People who have unstable diabetes or Type 1 (insulin-dependent) diabetes.
People who have a history of low blood sugar episodes after the age of 2 years.
People who have been diagnosed with a condition where acid builds up in the body (metabolic or lactic acidosis), or whose relevant blood test result is below a certain level at the screening visit.
People who had kidney disease or poor kidney function before their brain tumour diagnosis.
People who have had heart failure requiring medication (including water tablets) within the two years before joining the study.
People who are currently taking part in another study focused on cognitive (thinking and memory) rehabilitation.
People who are currently taking or planning to take water tablets (diuretics).
People who are currently taking or planning to take certain other medications that interact with the kidneys or with the study drug — including a specific list of named medicines (confirm with trial site for the full list).
People who are currently taking or planning to take certain other medications that may interact with the study drug, including some medicines used for seizures, blood pressure, stomach acid, and other conditions (confirm with trial site for the full list).
People diagnosed with a specific type of anaemia called pernicious anaemia, identified through screening blood tests.
People who are currently taking metformin hydrochloride.
People with any other condition or diagnosis that, in the opinion of the trial doctor, could affect their ability to follow the study requirements, affect the results, or put them at risk.
People who are receiving palliative (end-of-life comfort) care.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Donald Mabbott, Ph.D., The Hospital for Sick Children
John Hunter Children's Hospital, New Lambton Heights, New South Wales
+612 4985 5612
Children's Hospital in Westmead, Westmead, New South Wales
Women and Childen's Hospital, Adelaide, North Adelaide
Monash Children's Hospital, Clayton, Victoria
+613 8572 3456
Royal Children's Hospital, Parkville, Victoria
+613 9345 9184
Perth Children's Hospital, Nedlands, Western Australia
+618 6456 3612
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT05230758
Sponsor: Donald Mabbott
Phase: Phase 3
Status: Recruiting
Condition: Brain Cancer
Trial contact: 416-813-7396
More information: https://clinicaltrials.gov/study/NCT05230758
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
People who finished primary treatment for medulloblastoma, ependymoma, craniopharyngioma, germ cell tumours, another brain tumour treated with radiation to the head, or radiation for relapsed ependymoma — and at least 3 weeks have passed since that treatment ended.
People aged 7 years to 21 years and 11 months at the time of joining the study.
People whose native language is English (or French at sites that accept French speakers), or who have had at least two years of schooling in English (or French at accepting sites).
People who are able to swallow tablets whole, crushed, or through a feeding tube, and are willing to follow the study medication schedule.
People whose kidneys are working well enough, as measured by a standard calculation using height and a blood test result (confirm with trial site for exact threshold).
People whose liver is functioning within acceptable ranges, based on specific blood test results (confirm with trial site for exact values).
People (or their parent or legal guardian, where applicable) who are willing and able to provide informed consent to participate.
Who may not be able to join:
People whose IQ score on a specific intelligence test falls below 60 at the screening visit.
People who have a known allergy or sensitivity to metformin hydrochloride (the study drug).
People who have unstable diabetes or Type 1 (insulin-dependent) diabetes.
People who have a history of low blood sugar episodes after the age of 2 years.
People who have been diagnosed with a condition where acid builds up in the body (metabolic or lactic acidosis), or whose relevant blood test result is below a certain level at the screening visit.
People who had kidney disease or poor kidney function before their brain tumour diagnosis.
People who have had heart failure requiring medication (including water tablets) within the two years before joining the study.
People who are currently taking part in another study focused on cognitive (thinking and memory) rehabilitation.
People who are currently taking or planning to take water tablets (diuretics).
People who are currently taking or planning to take certain other medications that interact with the kidneys or with the study drug — including a specific list of named medicines (confirm with trial site for the full list).
People who are currently taking or planning to take certain other medications that may interact with the study drug, including some medicines used for seizures, blood pressure, stomach acid, and other conditions (confirm with trial site for the full list).
People diagnosed with a specific type of anaemia called pernicious anaemia, identified through screening blood tests.
People who are currently taking metformin hydrochloride.
People with any other condition or diagnosis that, in the opinion of the trial doctor, could affect their ability to follow the study requirements, affect the results, or put them at risk.
People who are receiving palliative (end-of-life comfort) care.
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 15 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 3
Sponsor
Donald Mabbott
Registry
ClinicalTrials.gov
Start date
1 July 2022
Est. completion
30 November 2027
Where this trial is recruiting
🇦🇺 Australia
🇨🇦 Canada
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change from Week 1 (Baseline) Children's Auditory Verbal Learning Test-2 (CAVLT-2)/Rey Auditory Verbal Learning Test (RAVLT) Immediate Recall at Week 17 (Post-Intervention) to Assess Declarative Memory; Change from Week 1 (Baseline) NIH Toolbox List Sort Working Working Memory Test at Week 17 (Post-Intervention) to Assess Working Memory; Change from Week 1 (Baseline) Cambridge Neuropsychological Test Automated Battery (CANTAB) Mean Reaction Time for Correct Trials across the RVP, RTI, MTS, and DMS Subtests at Week 17 (Post-Intervention) to Assess Processing Speed
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.