drugset / Trial / NCT00766467
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas
Phase 2
Completed
81 enrolled
Eudocia Quant Lee, MD
Beth Israel Deaconess Medical Center · collabCephalon · collabDartmouth-Hitchcock Medical Center · collabUniversity of California, San Diego · collab
RandomizedParallel-groupDouble-blindSupportive care
Summary
The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.
Timeline
- Start
- 2008-09
- Primary completion
- 2014-07
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Armodafinil | Small molecule | — | Oral |