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

Sponsor
Donald Mabbott
Study ID
NCT05230758
Phase
PHASE3
Status
Recruiting
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Conditions

  • Cognitive Impairment
  • Medulloblastoma, Childhood

Eligibility Criteria

Sex
ALL
Age
7 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin hydrochloride (HCl) 500mg tablet — DRUG
    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 — DRUG
    Matching white round tablet containing excipients only. The placebo tablets will match the active drug as closely as possible in terms of appearance.

Study Details

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?

Key Dates

Start date
Jul 1, 2022
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Metformin
    Oral metformin will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).
  • Placebo Comparator: Placebo
    Oral placebo will be administered approximately 500mg/m2/day for 1 week and increased to 1000mg/m2/day for 15 weeks. Doses will be rounded to increments of half tablets (250mg, 500mg, 750mg and 1000mg).

Primary Outcome Measure

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 [ Time Frame: Week 1 (Baseline), Week 17 (Post-Intervention) ]

Central Contacts

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