A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma
A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma
This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.
Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue Brief Fatigue Inventory (BFI) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.
The secondary objectives of the study are listed below.
Patients will receive armodafinil or placebo for a total of 8 weeks.
Inclusion Criteria:
Burbank, California 91505, United States
Washington D.C., District of Columbia 20002, United States
Miami, Florida 33136, United States
Highland Park, Illinois 60035, United States
West Branch, Michigan 48661, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
East Syracuse, New York 13057, United States
New York, New York 10032, United States
Spartanburg, South Carolina 29307, United States
Yakima, Washington 98902, United States