Clinical Research Directory
Browse clinical research sites, groups, and studies.
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Sponsor: Donald Mabbott
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
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.
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