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NCT01330446 · ClinicalTrials.gov registry record · Phase 1
Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01330446: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01330446 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01330446, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.
Primary Outcome
The primary outcome measure is item 3 on the Brief Fatigue Inventory (BFI) scale: "Please rate your fatigue (weariness, tiredness) by circling the one number that best describes your WORST level of fatigue during past 24 hours." The item is on a 10-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine). Thus, higher values represent worse outcomes. The primary outcome measure is the area under the curve (AUC), using the trapezoidal rule, for the BFI-Worst Fatigue scores over 28
Interventions
- OTHER Placebo
- BEHAVIORAL Questionnaires
- DRUG Armodafinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-05-19 |
| Est. Completion | 2022-12-08 |
| Phase | Phase 1 |
What the finished NCT01330446 record still lists
NCT01330446 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01330446 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01330446 about?
NCT01330446 is a clinical study titled "Single Agent Armodafinil for Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer". The goal of this clinical research study is to learn if armodafinil can reduce fatigue and other common symptoms in patients that have received treatment for head and neck cancer.
What is the current status of trial NCT01330446?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2011-05-19. Estimated completion is 2022-12-08.
What interventions are being tested in trial NCT01330446?
The interventions under investigation include: Placebo (OTHER), Questionnaires (BEHAVIORAL), Armodafinil (DRUG).
Who is sponsoring clinical trial NCT01330446?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01330446's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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