Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT01400958
Brief 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.
Study:
NCT01400958
Study Brief:
Protocol Section:
NCT01400958