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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 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.

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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.

Interventions

  • DRUG Placebo
  • DRUG Nuvigil®

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2010-12
Est. Completion 2013-09
Phase Phase 2

What the Registry Record Tells You About NCT01400958

The ClinicalTrials.gov registry entry for NCT01400958 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01400958 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.