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NCT01781468 · ClinicalTrials.gov registry record · Phase 3
Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
NCT01781468: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01781468 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 328 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01781468, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
Study Summary
This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.
Primary Outcome
A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks. Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome
Interventions
- OTHER Placebo
- DRUG armodafinil 150 mg
- DRUG armodafinil 250 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2013-06-21 |
| Est. Completion | 2019-12-15 |
| Phase | Phase 3 |
What the finished NCT01781468 record still lists
NCT01781468 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01781468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01781468 about?
NCT01781468 is a clinical study titled "Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma". This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.
What is the current status of trial NCT01781468?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2013-06-21. Estimated completion is 2019-12-15.
What interventions are being tested in trial NCT01781468?
The interventions under investigation include: Placebo (OTHER), armodafinil 150 mg (DRUG), armodafinil 250 mg (DRUG).
Who is sponsoring clinical trial NCT01781468?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01781468's enrollment target sits among peer trials
328 1074th of 2000 higher than 926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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