Actively Recruiting
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Led by Donald Mabbott · Updated on 2026-05-01
140
Participants Needed
20
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 3 weeks post completion of primary therapy for medulloblastoma, ependymoma, craniopharyngioma, germ cell tumours, or other brain tumours treated with cranial radiation, or cranial radiation for relapsed ependymoma
- Aged between 7 years and 21 years 11 months at enrollment
- Native English or French speaker, or at least two years of schooling in English or French
- Able and willing to swallow tablets whole, crushed, or via feeding tube and adhere to the treatment regimen
- Normal kidney function with estimated glomerular filtration rate (eGFR) over 75 ml/min/1.73m²
- Normal liver function with specific limits for AST, ALT, and total bilirubin levels
- Provided informed consent and assent if applicable
You will not qualify if you...
- Full scale IQ score below 60 on Wechsler intelligence scales at screening
- Known allergy to metformin hydrochloride
- Unstable or insulin-dependent (Type 1) diabetes
- History of hypoglycemia after age 2
- Diagnosis of acute or chronic metabolic or lactic acidosis, or low bicarbonate levels at screening
- History of kidney disease before brain tumour diagnosis
- History of congestive heart failure requiring treatment within 2 years prior to study
- Currently in a cognitive rehabilitation study
- Treatment with or planned use of diuretics or certain kidney-excreted cationic drugs
- Treatment with medications that may interact with metformin including lamotrigine, beta blockers, ACE inhibitors, glycopyrrolate, carbonic anhydrase inhibitors, or others at investigator discretion
- Pernicious anemia at screening
- Current use of metformin
- Any condition that may interfere with study compliance or safety as judged by investigators
- Receiving palliative care
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
John Hunter Children's Hospital
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
2
Children's Hospital in Westmead
Westmead, New South Wales, Australia, 2145
Withdrawn
3
Women and Childen's Hospital
Adelaide, North Adelaide, Australia, SA 5006
Actively Recruiting
4
Monash Children's Hospital
Clayton, Victoria, Australia, 3168
Actively Recruiting
5
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
6
Perth Children's Hospital
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
7
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
8
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
9
Children's & Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Actively Recruiting
10
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Actively Recruiting
11
Izaak Walton Killam (IWK) Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
12
Hamilton Health Sciences - McMaster Children's Hospital
Hamilton, Ontario, Canada, L8S 4K1
Actively Recruiting
13
Children's Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
14
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
15
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
16
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
17
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
18
CHU de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G2
Actively Recruiting
19
CHU de Sherbrooke
Sherbrooke, Quebec, Canada, J1G 2E8
Actively Recruiting
20
Saskatchewan Health Authority
Saskatoon, Saskatchewan, Canada, S7N 0W8
Actively Recruiting
Research Team
L
Lauren Cole, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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