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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
Must not have
Have unstable and/or insulin-dependent (Type 1) diabetes
Current use of metformin hydrochloride
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 (baseline), week 17 (post-intervention)
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have Type 1 diabetes that is not well-controlled.
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I am currently taking metformin.
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I have experienced low blood sugar after turning 2 years old.
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I have a history of kidney problems.
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I am currently taking or will be taking water pills.
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I have been diagnosed with a high level of acid in my blood or a lactate level over 5.
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I am taking or will take medication that affects my kidneys.
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I cannot undergo an MRI without being sedated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 (baseline), week 17 (post-intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 (baseline), week 17 (post-intervention) for reporting.

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

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

Metformin hydrochloride (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT05230758 — Phase 3
Medulloblastoma Research Study Groups: Metformin, Placebo
Medulloblastoma Clinical Trial 2023: Metformin hydrochloride Highlights & Side Effects. Trial Name: NCT05230758 — Phase 3
Metformin hydrochloride (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230758 — Phase 3
~83 spots leftby Jun 2027