drugset / Trial / NCT01400958

Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

NCT01400958

RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2010-12
Primary completion
2012-12
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Armodafinil Small molecule 150 mg

Indications