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NCT01400958 · ClinicalTrials.gov registry record · Phase 2
Nuvigil or Placebo in Newly Diagnosed Malignant Glioma
A Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01400958: Clinical Trial Phase 2 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01400958 is a Phase 2 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01400958, a Phase 2 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people receiving external beam radiation therapy for the treatment of malignant gliomas. It is also being done to determine if Nuvigil® improves cognitive function (perception, thinking, reasoning, and remembering) and overall quality of life in people receiving external beam radiation therapy for the treatment of malignant gliomas. Another purpose of this study is to see if people who receive Nuvigil® have more or less side effects than people who receive placebo. Placebo is a substance that looks like an active drug but has no active ingredient.
Primary Outcome
Determine if Nuvigil® improves fatigue experienced by patients receiving external beam radiation therapy for the treatment of malignant gliomas. Participants who maintained minimal, or experienced improved fatigue experience on a scale of 0 (No fatigue) - 10 (As bad as you can imagine).
Interventions
- DRUG Placebo
- DRUG Nuvigil®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
Why NCT01400958 stopped before completion
NCT01400958 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01400958 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01400958 about?
NCT01400958 is a clinical study titled "Nuvigil or Placebo in Newly Diagnosed Malignant Glioma". The purpose of this study is to determine if Nuvigil® improves fatigue experienced by people receiving external beam radiation therapy for the treatment of malignant gliomas. It is also being done to determine if Nuvigil® improves cognitive function (perception, thinking, reasoning, and remembering)...
What is the current status of trial NCT01400958?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2010-12. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01400958?
The interventions under investigation include: Placebo (DRUG), Nuvigil® (DRUG).
Who is sponsoring clinical trial NCT01400958?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01400958's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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