Phase 2
Completed N=112
Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor
Brain Cancer · Cognitive/Functional Effects · Fatigue · Neurotoxicity
Source: ClinicalTrials.gov NCT01381718 ↗
Enrolled (actual)
112
Serious AEs
0.9%
Results posted
Aug 2021
Primary outcomePrimary: Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery — -0.16; 0.14 Z Score
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Age-Adjusted Scores at Week Six From Baseline in the Attention Task of the CogState Battery |
-0.16; 0.14 | — |
| SECONDARY Number of Reported Adverse Events (AEs) |
76; 26 | — |
| SECONDARY Change in Working Memory Score at 6 Weeks From Baseline as Assessed on BRIEF |
-4.1; -4.5 | — |
| SECONDARY Change in PedsQL Score at 6 Weeks From Baseline |
11.3; 11.4; 9.3; 6.9 | — |
Eligibility Criteria
INCLUSION CRITERIA
- Age ≥ 6 years and ≤ 18 years 10 months at the time of study entry (so that participants will be Tanner stage 2, except for those who have documented pan pituitary insufficiency or other hormonal state incompatible with pregnancy.
- Urine pregnancy tests are acceptable.
EXCLUSION CRITERIA
- Off treatment > 14 years
- Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or IQ 2 weeks prior to study enrollment.
- Treatment with other stimulant medications within 14 days of registration; however, a diagnosis of ADHD does NOT exclude a child from participation
- Participants with known hypersensitivity to modafinil, armodafinil or any of its components
Data sourced from ClinicalTrials.gov (NCT01381718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.