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Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma


Title A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma 
Therapeutic Area Brain Cancer, Brain Tumors
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender All
Contact Amanda Campbell
617-636-2883
More Information https://www.clinicaltrials.gov/ct2/show/NCT01781468

Overview

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. 

Study Details

Inclusion Criteria

  • Subjects must have glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma
  • Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy
  • Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria

  • Pregnant and/or nursing women. Men or women of childbearing potential who are unwilling to employ adequate contraception
  • History of hypersensitivity to other psycho-stimulants
  • History of steroid psychosis

Study Requirements

Subjects will be randomized to take the study drug, armodafinil at 150mg, armodafinil at 250mg, or placebo. Subjects will take the study drugs every day for 8 weeks. Subjects will be asked to fill out 
questionnaires and undergo neurocognitive tests at baseline, after 4 weeks taking the study drug, and after 8 weeks taking the study drug.