Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour (NCT05230758) | Clinical Trial Compass
RecruitingPhase 3
Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Australia140 participantsStarted 2022-07-01
Plain-language 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?
Who can participate
Age range7 Years – 21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. No less than 3 weeks after completion of:
✓. medulloblastoma
✓. ependymoma
✓. craniopharyngioma
✓. germ cell tumours
✓. Age 7 years to 21 years and 11 months at the time of enrollment
✓. Either declare English (or French in accepting sites) as their native language or have had at least two years of schooling in English (or French in accepting sites) at the time of consent
✓. Able to swallow tablets either whole, crushed or via a feeding tube and be willing to adhere to the study intervention regimen
Exclusion criteria
✕. Standard score of less than 60 for full scale IQ on the Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II) (or other Wechsler Scale of Intelligence for English speaking participants) or pro-rated IQ score on the Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V) or Wechsler Adult Intelligence Scale (WAIS-IV) for French speaking participants at Screening visit
What they're measuring
1
Change from Week 1 (Baseline) Children's Auditory Verbal Learning Test-2 (CAVLT-2)/Rey Auditory Verbal Learning Test (RAVLT) Immediate Recall at Week 17 (Post-Intervention) to Assess Declarative Memory
Change from Week 1 (Baseline) Cambridge Neuropsychological Test Automated Battery (CANTAB) Mean Reaction Time for Correct Trials across the RVP, RTI, MTS, and DMS Subtests at Week 17 (Post-Intervention) to Assess Processing Speed
✕. Have a known hypersensitivity to metformin hydrochloride
✕. Have unstable and/or insulin-dependent (Type 1) diabetes
✕. Have a history of hypoglycemia after 2 years of age
✕. Have been diagnosed with acute or chronic metabolic acidosis and/or lactic acidosis or if bicarbonate (Total CO2) is less than 22 mmol/L at the Screening visit
✕. Have a history of renal disease or renal dysfunction pre-existing to the diagnosis of Medulloblastoma
✕. Have a history of congestive heart failure requiring pharmacologic treatment (including the use of diuretics) within two years prior to study entry
✕. Currently taking part in a cognitive rehabilitation intervention study