A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment

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

- Life expectancy of six months or greater

- 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)

- A history of 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