SCUSF 0901 [ACCL0922]: A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
1. To determine whether a 6-week drug trial of modafinil, compared to placebo, is associated with improvement in neurocognitive function as defined by parent report of inattention or working memory deficits or by direct assessment of attention, working memory or processing speed in children with cognitive impairment after treatment for a primary brain tumor. 2. To determine whether modafinil, compared to placebo, is associated with improved executive function (apart from working memory), as assessed using the BRIEF executive function and hippocampal learning and executive function tasks from the CogState battery. 3. Determine whether modafinil, compared to placebo, is associated with reduced fatigue as assessed using the PedsQL Multidimensional Fatigue Scale. 4. Evaluate the safety of modafinil in this population.
Keywordsmodafinil, placebo, neurocognitive function, Children, Brain Tumor
Principal InvestigatorAmanda Visek
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