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Nuvigil or Placebo in Newly Diagnosed Malignant Glioma

NCT01400958 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-12-16

Study results available
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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.

Conditions

  • Malignant Glioma

Interventions

DRUG

Nuvigil®

Nuvigil® 150 mg/day x 42 days THEN, No More Drug

DRUG

Placebo

Placebo x 42 days; THEN, No More Placebo

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Peter Forsyth, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400958 on ClinicalTrials.gov