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

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