A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

- Since no one knows for certain if armodafinil improves fatigue in brain tumor patients
undergoing radiation therapy, participants will be randomized into one of two study
groups. Half of the participants will receive armodafinil and the other half will
receive pills with no medicine (placebo). Neither the participant or the study doctor
will know what group they are in.

- Participants will be given a study medication-dosing calendar and will take either the
study drug or placebo orally once a day for 8 weeks. The dose will be adjusted on days
8,22 or 43, depending upon the level of fatigue. Treatment will begin within 10 days
from the radiation start date.

- Participants will be evaluated via documented clinician telephone call and
self-administered questionnaires on days 1, 8, 22, 43 and 57.

Inclusion Criteria:

- 18 years of age or older

- Histologically confirmed malignant glioma including anaplastic astrocytoma,
anaplastic oligodendroglioma, anaplastic oligoastrocytoma (WHO grade III/IV),
glioblastoma multiforme (WHO grade IV) or gliosarcoma. Patients with a grade II
astrocytoma, mixed oligo-astrocytoma or oligodendroglioma who are being treated with
irradiation are also eligible

- Scheduled to receive irradiation to a total dose of 50-60 Gy. Patients receiving
hyperfractionated radiotherapy are also eligible

- KPS of 70% or greater

- Electrolytes within normal institutional limits: BUN and Creatinine < 2.5 x ULN: AST,
ALT, Bilirubin < 2.5 x ULN

- Able to swallow medication

Exclusion Criteria:

- History of recent cardiac arrhythmia or unstable angina

- Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis
within the past 30 days

- Clinically significant untreated sleep apnea

- A history of clinically significant cardiac disease, including a history of recent
myocardial infarction, history of unstable angina, history of left ventricular
hypertrophy, or a history of ischemic ECG changes, chest pain, arrhythmia, or other
clinically significant manifestations of mitral valve prolapse in association with
use of CNS stimulants (e.g. caffeine, amphetamines, methylphenidate)

- Uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma,
narcolepsy, clinically significant untreated sleep apnea, psychotic disorder or
Tourette's syndrome

- Patients taking warfarin for anticoagulation are eligible, but monitoring of
prothrombin times is suggested as a precaution

- Hemoglobin level of less then 11 g/dl

- Laboratory evidence of hypothyroidism with an elevated TSH concentration in the blood
greater than 5.0 mlU/L

- Current treatment or history of psychotic disorder, bipolar disorder, or anxiety
disorder

- Patients with a score of > 28 on the Beck depression inventory consistent with severe
depression

- Known hypersensitivity to armodafinil or related compounds

- Patients who have been receiving MAO inhibitors during the past 14 days