Effect of Metformin on Behaviour and the Brain in Children Treated for a Brain Tumour
Recruiting
Phase 3
Interventional Study
Medulloblastoma, Childhood
Cognitive Impairment
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 7 – 21
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 140 (estimated)
- Sponsor
- Donald Mabbott · Other
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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 ad…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. No less than 3 weeks after completion of:
* Primary therapy for:
1. medulloblastoma
OR
2. ependymoma
OR
3. craniopharyngioma
…
Contacts