Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age7-21
SponsorDonald Mabbott
About this trial
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?
Eligibility criteria
Qualifiers
medulloblastoma
ependymoma
craniopharyngioma
germ cell tumours
Disqualifiers
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
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
Trial design
Treatments tested in this trial
- Metformin hydrochloride (HCl) 500mg tablet
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Donald Mabbott
Lead sponsor
The Hospital for Sick Children
Sponsor institution
Source ClinicalTrials.gov