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RECRUITING
NCT05230758
PHASE3

Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour

Sponsor: Donald Mabbott

View on ClinicalTrials.gov

Summary

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?

Official title: Phase III Randomized Double-blind Placebo-controlled Trial of Metformin for Cognitive Recovery and White Matter Growth in Paediatric Patients With a Brain Tumour

Key Details

Gender

All

Age Range

7 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2022-07-01

Completion Date

2027-11-30

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Placebo

Matching white round tablet containing excipients only. The placebo tablets will match the active drug as closely as possible in terms of appearance.

Locations (20)

John Hunter Children's Hospital

New Lambton Heights, New South Wales, Australia

Children's Hospital in Westmead

Westmead, New South Wales, Australia

Women and Childen's Hospital

Adelaide, North Adelaide, Australia

Monash Children's Hospital

Clayton, Victoria, Australia

Royal Children's Hospital

Parkville, Victoria, Australia

Perth Children's Hospital

Nedlands, Western Australia, Australia

Alberta Children's Hospital

Calgary, Alberta, Canada

Stollery Children's Hospital

Edmonton, Alberta, Canada

Children's & Women's Health Centre of British Columbia

Vancouver, British Columbia, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Izaak Walton Killam (IWK) Health Centre

Halifax, Nova Scotia, Canada

Hamilton Health Sciences - McMaster Children's Hospital

Hamilton, Ontario, Canada

Children's Hospital, London Health Sciences Centre

London, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

CHU Sainte-Justine

Montreal, Quebec, Canada

Montreal Children's Hospital

Montreal, Quebec, Canada

CHU de Québec - Université Laval

Québec, Quebec, Canada

CHU de Sherbrooke

Sherbrooke, Quebec, Canada

Saskatchewan Health Authority

Saskatoon, Saskatchewan, Canada