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Anti-diabetic drug
Metformin for Medulloblastoma Recovery (Met Med Can Trial)
Phase 3
Recruiting
Led By Eric Bouffet, M.D.
Research Sponsored by Donald Mabbott
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Normal renal function defined as: Estimated glomerular filtration rate (eGFR) > 75ml/min/1.73m²
Total bilirubin <1.5 institutional ULN for age and gender
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 (baseline), week 17 (post-intervention)
Awards & highlights
Met Med Can Trial Summary
This trial will investigate whether metformin can help children/adolescents recover cognitively and grow brain tissue after treatment for medulloblastoma.
Who is the study for?
Children aged 7 to 17 years and 11 months who have finished treatment for medulloblastoma, a type of brain tumor. They must be able to swallow tablets, have normal kidney and liver function, speak English or French fluently or have been schooled in these languages for at least two years. Participants should not have severe low blood sugar history, metabolic acidosis, heart failure requiring medication within the past two years, unstable diabetes, or known allergies to metformin.Check my eligibility
What is being tested?
The trial is testing if metformin can help improve cognitive function and brain growth after treatment for medulloblastoma compared to a placebo. It's a Phase III study where participants are randomly assigned either metformin or placebo for 16 weeks in a double-blind setup (neither doctors nor patients know who gets what).See study design
What are the potential side effects?
Metformin may cause side effects like stomach upset, diarrhea, low blood sugar levels (hypoglycemia), lactic acid buildup in the body (lactic acidosis), vitamin B12 deficiency over long-term use which could lead to anemia or nerve problems.
Met Med Can Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal, with an eGFR over 75.
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My bilirubin levels are within the normal range for my age and gender.
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My liver enzyme (ALT) levels are within the normal range for my age and gender.
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I am between 7 and 17 years old.
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My liver enzyme AST levels are within the normal range for my age and gender.
Met Med Can Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1 (baseline), week 17 (post-intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 (baseline), week 17 (post-intervention)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Child health care
Change from Week 1 (Baseline) NIH Toolbox List Sort Working Working Memory Test at Week 17 (Post-Intervention) to Assess Working Memory
Secondary outcome measures
Diffusion Kurtosis Imaging (DKI) to Assess White Matter Growth within the Corpus Callosum
Met Med Can Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
Oral metformin will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).
Group II: PlaceboPlacebo Group1 Intervention
Oral placebo will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).
Find a Location
Who is running the clinical trial?
Donald MabbottLead Sponsor
Donald Mabbott, Ph.D.Study ChairThe Hospital for Sick Children
1 Previous Clinical Trials
28 Total Patients Enrolled
Eric Bouffet, M.D.Principal InvestigatorThe Hospital for Sick Children
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Type 1 diabetes that is not well-controlled.You are allergic to metformin hydrochloride.My kidney function is normal, with an eGFR over 75.My bilirubin levels are within the normal range for my age and gender.My liver enzyme (ALT) levels are within the normal range for my age and gender.I am currently taking metformin.I have experienced low blood sugar after turning 2 years old.I have a history of kidney problems.I am currently taking or will be taking water pills.I can take pills whole, crushed, or through a feeding tube and will follow the study plan.It has been over 3 weeks since I finished my main treatment for medulloblastoma.I am not taking any medications that could badly interact with metformin.I have been treated for heart failure with medication in the last two years.My liver is working normally.I am between 7 and 17 years old.I have been diagnosed with a high level of acid in my blood or a lactate level over 5.I am taking or will take medication that affects my kidneys.My liver enzyme AST levels are within the normal range for my age and gender.English (or French) is my native language or I've studied it for at least two years.My organs are functioning normally.I cannot undergo an MRI without being sedated.You are currently participating in a study that helps improve cognitive abilities.
Research Study Groups:
This trial has the following groups:- Group 1: Metformin
- Group 2: Placebo
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are investigators still recruiting people for this research project?
"This particular clinical trial, as indicated by clinicaltrials.gov, is recruiting patients at this time. It was initially posted on 7/1/2022, with the most recent update being on 9/7/2022."
Answered by AI
Could you please list the prerequisites for participating in this research project?
"This trial is admitting 140 patients with medulloblastoma, childhood aged 7 and 17. Most importantly, applicants are required to meet the following criteria: No less than 3 weeks after completion of primary therapy for medulloblastoma, Age 7 years to 17 years and 11 months at the time of enrollment, Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen, Normal renal function defined as: Estimated glomerular filtration rate (eGFR) > 75ml/min/1.73m², eGFR is calculated using the Schwartz"
Answered by AI
Does this research allow for subjects who are geriatric?
"According to the age parameters set out in the eligibility requirements, the youngest a patient can be is 7 years old and the oldest is 17."
Answered by AI
Is there a risk to patients who take Metformin hydrochloride (HCl) 500mg tablet?
"Although it is Phase 3, there is data supporting efficacy and safety, so our team gave it a score of 3."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Izaak Walton Killam (IWK) Health Centre
What portion of applicants met pre-screening criteria?
Did not meet criteria
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