drugset / Trial / NCT05230758

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

NCT05230758 ↗

Phase 3 Recruiting 140 enrolled Donald Mabbott
RandomizedParallel-groupQuadruple-blindSupportive care

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?

Timeline

Start
2022-07-01
Primary completion
2027-11-30
Completion
2027-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 1000 mg/m2 Oral