Testing Metformin hydrochloride (HCl) against a placebo for childhood medulloblastoma
Official title: Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Phase III Randomized Double-blind Placebo-controlled Trial of Metformin for Cognitive Recovery and White Matter Growth in Paediatric Patients With a Brain Tumour
- Phase 3
- 2 groups
- Sites in Calgary, Edmonton and 11 more cities
- Recruiting
Interventions
- Medication
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.
- Medication
Placebo
Matching white round tablet containing excipients only. The placebo tablets will match the active drug as closely as possible in terms of appearance.
Canadian Sites (14)
14 of 14 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
- Recruiting
Stollery Children's Hospital
Edmonton, Alberta
- Recruiting
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia
- Recruiting
Cancer Care Manitoba
Winnipeg, Manitoba
- Recruiting
Izaak Walton Killam (IWK) Health Centre
Halifax, Nova Scotia
- Recruiting
Hamilton Health Sciences - McMaster Children's Hospital
Hamilton, Ontario
- Recruiting
Children's Hospital, London Health Sciences Centre
London, Ontario
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
- Recruiting
CHU Sainte-Justine
Montreal, Quebec
- Recruiting
Montreal Children's Hospital
Montreal, Quebec
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec
- Recruiting
CHU de Sherbrooke
Sherbrooke, Quebec
- Recruiting
Saskatchewan Health Authority
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for36 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Normal renal function defined as: Estimated glomerular filtration rate (eGFR) \> 75ml/min/1.73m²
- +In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- +No less than 3 weeks after completion of:
- +Primary therapy for:
- +medulloblastoma
- +ependymoma
- +craniopharyngioma
- +germ cell tumours
- +Age 7 years to 21 years and 11 months at the time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen
- +Meet criteria for normal organ function requirements as described below:
- +eGFR is calculated using the Schwartz formula: eGFR (mL/min/1.73m²) = (0.41 × height in cm) / creatinine in mg/dL
- +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 SponsorSponsorThe organisation responsible for the study overall.Read more → approval and total bilirubin ≤2.0 x institutional ULN)
- +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
- +Primary therapy for any other brain tumour treated with cranial radiation - at the discretion of the Study PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
- +Cranial radiation for relapsed ependymoma
Exclusion
- −Have a known hypersensitivity to metformin hydrochloride
- −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 SiteTrial siteA hospital or clinic where a study is actually run.Read more → PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or delegate for medications with potential interactions such as sertraline, lansoprazole and omeprazole.
- −Participants who meet any of the following criteria will not be eligible to take part in the trial:
- −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 visitScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Have unstable and/or insulin-dependent (Type 1) diabetes
- −Have a history of hypoglycemia after 2 years of age
- −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
- −Have a history of renal disease or renal dysfunction pre-existing to the diagnosis of Medulloblastoma
- −Have a history of congestive heart failure requiring pharmacologic treatment (including the use of diuretics) within two years prior to study entry
- −Currently taking part in a cognitive rehabilitation intervention study
- −Treatment or planned treatment involving diuretics
- −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)
- −Pernicious anemia (according to results of the Screening visit blood draw)
- −Current use of metformin hydrochloride
- −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
- −Are receiving palliative care
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Metformin hydrochloride (HCl) 500mg tablet.
Registry label: A: Metformin
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 7 years to 21 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 140 people.
The study is currently expected to finish around November 2027.
The main measurement is taken over: Week 1 (BaselineBaselineYour starting measurements, taken before treatment begins.Read more →), Week 17 (Post-Intervention).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from Week 1 (BaselineBaselineYour starting measurements, taken before treatment begins.Read more →) 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 — measured over Week 1 (Baseline), Week 17 (Post-Intervention).
Change from Week 1 (Baseline) NIH Toolbox List Sort Working Working Memory Test at Week 17 (Post-Intervention) to Assess Working Memory — measured over Week 1 (Baseline), Week 17 (Post-Intervention).
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 — measured over Week 1 (Baseline), Week 17 (Post-Intervention).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05230758 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Metformin hydrochloride (HCl) 500mg tabletDrug
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.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Matching white round tablet containing excipients only. The placebo tablets will match the active drug as closely as possible in terms of appearance.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 7 years to 21 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 7 years to 21 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 1 (BaselineBaselineYour starting measurements, taken before treatment begins.Read more →), Week 17 (Post-Intervention).
The study as a whole is currently expected to finish around 2027-11-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 140 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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?
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.