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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

All Individual Drugs Already Approved

Approved for 20 Other Conditions

Pivotal 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.

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).

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 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)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Diffusion Kurtosis Imaging (DKI) to Assess White Matter Growth within the Corpus Callosum

Awards & Highlights

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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).

0 / 13Eligibility criteria met