NCT01781468

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

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue Brief Fatigue Inventory (BFI) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma. The secondary objectives of the study are listed below. 1. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population. 2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma. 3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma. 4. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as, the relationship of fatigue and cognitive difficulties. Patients will receive armodafinil or placebo for a total of 8 weeks.

Conditions

• Fatigue

Interventions

Type	Name	Description
DRUG	armodafinil 150 mg	given orally
OTHER	Placebo	given orally
DRUG	armodafinil 250 mg	given orally

Timeline

• Start date: 2013-06-21
• Primary completion: 2019-05-01
• Completion: 2019-12-15
• First posted: 2013-02-01
• Last updated: 2025-01-27
• Results posted: 2020-05-07

Locations

365 sites across 1 country: United States