drugset / Trial / NCT05230758
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 1000 mg/m2 | Oral |