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CNS Stimulant

Armodafinil for Head and Neck Cancers

Phase 1 & 2
Waitlist Available
Led By Gary B. Gunn, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks
Awards & highlights

Study Summary

This trial will test if armodafinil can help relieve fatigue and other symptoms in people who have been treated for head and neck cancer.

Eligible Conditions
  • Head and Neck Cancer
  • Fatigue

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brief Fatigue Inventory-Worst

Side effects data

From 2010 Phase 4 trial • 385 Patients • NCT01080807
15%
Headache
11%
Nausea
7%
Insomnia
4%
Dry mouth
100%
80%
60%
40%
20%
0%
Study treatment Arm
150 mg/Day Armodafinil
Matching Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ArmodafinilExperimental Treatment2 Interventions
50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.
Group II: PlaceboPlacebo Group2 Interventions
1 Placebo by mouth every morning for a 28 day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Armodafinil
2013
Completed Phase 4
~3070
Questionnaires
2013
Completed Phase 2
~3330

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,755 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,127 Total Patients Enrolled
Gary B. Gunn, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

Armodafinil (CNS Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT01330446 — Phase 1 & 2
Head and Neck Cancers Research Study Groups: Armodafinil, Placebo
Head and Neck Cancers Clinical Trial 2023: Armodafinil Highlights & Side Effects. Trial Name: NCT01330446 — Phase 1 & 2
Armodafinil (CNS Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01330446 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there participation opportunities for volunteers in this experiment?

"The clinicaltrial.gov database indicates that this project is no longer recruiting participants, having first been posted on May 19th 2011 and last updated November 17th 2022. Nonetheless, 617 other studies are still welcoming enrollees at present."

Answered by AI

How many participants are currently enrolled in the experiment?

"At the moment, this trial is not enrolling. It was first posted on May 19th 2011 and last updated November 17th 2022. Alternatively, there are 616 studies accepting patients with fatigue symptoms and 1 study admitting participants for Armodafinil trials."

Answered by AI

What experimental evidence exists regarding the effects of Armodafinil?

"Currently, there is one ongoing investigation into the impacts of Armodafinil and none are in their concluding phase. Houston, Texas holds most of these trials with two other clinical sites also involved."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer
2011. "Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01330446.
~2 spots leftby Apr 2025
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