A Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Nuvigil® (Armodafinil) in Newly Diagnosed Malignant Glioma Patients Experiencing Fatigue Secondary to External Beam Radiation Therapy and Concurrent Temozolomide
Study visit times will correspond with standard follow-up evaluations for the patient's
Study visits will occur at baseline (Week 0); Week 7, which is when patients stop their use
of study drug and their first round of external beam radiation therapy and temozolomide; and
at Weeks 10, 18, and 34.
The Week 7 evaluation will include: neuropsychological exam, Psychosocial Questionnaires,
and questions about the patient's medications and health.
The Week 10 and 18 evaluations will include: vital sign measurements, Karnofsky Performance
status rating, neurological and neuropsychological exams, psychosocial questionnaires, an
Magnetic Resonance Imaging (MRI) of the patient's brain, and questions about their
medications and health.
The Week 34 evaluation will include: vital sign measurements, Karnofsky Performance status
rating, neurological and neuropsychological exams, psychosocial questionnaires, and
questions about the patient's medications and health.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Number of Participants With Improved Fatigue Experience
Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas.
36 weeks per participant
Peter Forsyth, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|