A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

NCT01400958

Malignant Glioma

TERMINATED PHASE2

Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

NCT00004129

Brain and Central Nervous System Tumors

UNKNOWN PHASE1

Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma

NCT03868943

Glioma Glioblastoma

TERMINATED PHASE2

Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma

NCT04047706

Glioblastoma

ACTIVE_NOT_RECRUITING PHASE1

Carmustine in Treating Patients With Recurrent Malignant Glioma

NCT00004028

Brain and Central Nervous System Tumors

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* Since no one knows for certain if armodafinil improves fatigue in brain tumor patients undergoing radiation therapy, participants will be randomized into one of two study groups. Half of the participants will receive armodafinil and the other half will receive pills with no medicine (placebo). Neither the participant or the study doctor will know what group they are in.
* Participants will be given a study medication-dosing calendar and will take either the study drug or placebo orally once a day for 8 weeks. The dose will be adjusted on days 8,22 or 43, depending upon the level of fatigue. Treatment will begin within 10 days from the radiation start date.
* Participants will be evaluated via documented clinician telephone call and self-administered questionnaires on days 1, 8, 22, 43 and 57.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Glioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Armodafinil

Group Type EXPERIMENTAL

Armodafinil

Intervention Type DRUG

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

Group 2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo taken once a day in the morning

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Armodafinil

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

Intervention Type DRUG

Placebo

Placebo taken once a day in the morning

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nuvigil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years of age or older
* Histologically confirmed malignant glioma including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma (WHO grade III/IV), glioblastoma multiforme (WHO grade IV) or gliosarcoma. Patients with a grade II astrocytoma, mixed oligo-astrocytoma or oligodendroglioma who are being treated with irradiation are also eligible
* Scheduled to receive irradiation to a total dose of 50-60 Gy. Patients receiving hyperfractionated radiotherapy are also eligible
* KPS of 70% or greater
* Electrolytes within normal institutional limits: BUN and Creatinine \< 2.5 x ULN: AST, ALT, Bilirubin \< 2.5 x ULN
* Able to swallow medication

Exclusion Criteria

* History of recent cardiac arrhythmia or unstable angina
* Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis within the past 30 days
* Clinically significant untreated sleep apnea
* A history of clinically significant cardiac disease, including a history of recent myocardial infarction, history of unstable angina, history of left ventricular hypertrophy, or a history of ischemic ECG changes, chest pain, arrhythmia, or other clinically significant manifestations of mitral valve prolapse in association with use of CNS stimulants (e.g. caffeine, amphetamines, methylphenidate)
* Uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, narcolepsy, clinically significant untreated sleep apnea, psychotic disorder or Tourette's syndrome
* Patients taking warfarin for anticoagulation are eligible, but monitoring of prothrombin times is suggested as a precaution
* Hemoglobin level of less then 11 g/dl
* Laboratory evidence of hypothyroidism with an elevated TSH concentration in the blood greater than 5.0 mlU/L
* Current treatment or history of psychotic disorder, bipolar disorder, or anxiety disorder
* Patients with a score of \> 28 on the Beck depression inventory consistent with severe depression
* Known hypersensitivity to armodafinil or related compounds
* Patients who have been receiving MAO inhibitors during the past 14 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No