CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
modafinil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01381718
NCT01381718Phase 2Completed
CompareCT.gov

A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor

University of South Florida·interventional·Posted Jun 27, 2011·Updated Aug 13, 2021

In Brief

A Phase 2 clinical trial evaluating modafinil and placebo for Brain and Central Nervous System Tumors and 4 related conditions. Completed, enrolled 112 participants across 60 sites.

Detailed Summary

RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment. PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue, Neurotoxicity, Psychosocial Effects of Cancer and Its Treatment
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 27, 2011
Enrollment StartAug 1, 2011
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.0 years ago

Interventions

modafinildrug

Given PO

placeboother

Given PO