CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Armodafinil +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00766467
NCT00766467Phase 2Completed
CompareCT.gov

A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment

Eudocia Quant Lee, MD·interventional·Posted Oct 6, 2008·Updated Jul 28, 2016

In Brief

A Phase 2 clinical trial evaluating Armodafinil and Placebo for Malignant Glioma. Completed, enrolled 81 participants across 4 sites.

Detailed Summary

The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Glioma
CountriesUnited States
CollaboratorsDartmouth-Hitchcock Medical Center, University of California, San Diego, Beth Israel Deaconess Medical Center, Cephalon

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 6, 2008
Enrollment StartSep 1, 2008
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.7 years ago

Interventions

Armodafinildrug

Taken orally once a day in the morning. Dose will change depending upon level of fatigue

Placeboother

Placebo taken once a day in the morning