drugset / Trial / NCT01160380

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma

NCT01160380 ↗

Phase 3 Completed 50 enrolled Oncotherapeutics Cephalon · collab
RandomizedCrossoverQuadruple-blindSupportive care

Summary

The purpose of this study is to evaluate the efficacy of armodafinil for the treatment of cancer-related fatigue in adult patients with multiple myeloma. The study consists of a screening period, followed by a 56-day treatment phase, and a final assessment to occur 28 days after the end of the last treatment.

Timeline

Start
2010-06
Primary completion
2013-06
Completion
2014-05

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Armodafinil vs Placebo-First; p = 0.289; Wilcoxon (Mann-Whitney) NCT01160380 ↗

registry analysis (superiority or other test); Armodafinil vs Placebo-First; p = 0.954; Wilcoxon (Mann-Whitney) NCT01160380 ↗

registry analysis (superiority or other test); Armodafinil vs Placebo-First; p = 0.699; t-test, 2 sided NCT01160380 ↗

registry analysis (superiority or other test); Armodafinil vs Placebo-First; p = 0.636; Wilcoxon (Mann-Whitney) NCT01160380 ↗

registry analysis (superiority or other test); Armodafinil vs Placebo-First; p = 0.531; Wilcoxon (Mann-Whitney) NCT01160380 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Armodafinil Small molecule 150 mg —

Indications