NCT01400958

Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people receiving external beam radiation therapy for the treatment of malignant gliomas. It is also being done to determine if Nuvigil® improves cognitive function (perception, thinking, reasoning, and remembering) and overall quality of life in people receiving external beam radiation therapy for the treatment of malignant gliomas. Another purpose of this study is to see if people who receive Nuvigil® have more or less side effects than people who receive placebo. Placebo is a substance that looks like an active drug but has no active ingredient.

Detailed description

Study visit times will correspond with standard follow-up evaluations for the patient's malignant glioma. 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.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
DRUG	Nuvigil®	Nuvigil® 150 mg/day x 42 days THEN, No More Drug
DRUG	Placebo	Placebo x 42 days; THEN, No More Placebo

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-12-01
• Completion: 2013-09-01
• First posted: 2011-07-25
• Last updated: 2013-12-16
• Results posted: 2013-12-16

Locations

1 site across 1 country: United States