A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00766467
Recruitment Status : Completed
First Posted : October 6, 2008
Results First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Dartmouth-Hitchcock Medical Center
University of California, San Diego
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Eudocia Quant Lee, MD, Dana-Farber/Brigham and Women's Cancer Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition: Malignant Glioma
Interventions: Drug: Armodafinil
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study activated at Dana-Farber Cancer Institute in August 2008 and was eventually activated at Beth Israel Medical Center , Dartmouth Hitchcock Medical Center, and University of California San Diego. The study closed to new accrual as of April 2014 as the accrual was met.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomization was performed by the Quality Assurance for Clinical Trials office at the Dana Farber Cancer Institute. Patients were randomized in a 1:1 basis to each treatment arm with no stratification.

Reporting Groups
Armodafinil Armodafinil: 150mg taken orally once a day in the morning.
Placebo Placebo: Taken orally once a day in the morning

Participant Flow:   Overall Study
    Armodafinil   Placebo
STARTED   42   39 
Initiated Treatment   39   38 
COMPLETED   31   31 
Withdrawal by Subject                7                2 
Adverse Event                1                1 
Protocol Violation                2                4 
Tumor Progression on Study                0                1 
Physician Decision                1                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Armodafinil Armodafinil: Taken orally once a day in the morning.
Placebo Placebo: Taken orally once a day in the morning.
Total Total of all reporting groups

Baseline Measures
   Armodafinil   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   39   81 
[Units: Years]
Median (Full Range)
 (25 to 79) 
 (19 to 78) 
 (19 to 79) 
[Units: Participants]
Female   18   18   36 
Male   24   21   45 
Karnofsky Performance Status (KPS) [1] 
[Units: Units on a scale]
Median (Full Range)
 (70 to 100) 
 (70 to 100) 
 (70 to 100) 
[1] Karnofsky Performance Status ranges from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease) in increments of 10. This was measured at baseline, prior to any treatment on study.
Glioma grade [1] 
[Units: Units on a scale]
Grade 2   1   4   5 
Grade 3   14   12   26 
Grade 4   25   22   47 
Grade not defined   2   1   3 
[1] Glioma is a broad category of brain and spinal cord. Gliomas can be grade I, II, III or IV. For the purposes of this study, Grade II, III, and IV were eligible for enrollment.

  Outcome Measures

1.  Primary:   Change From Baseline in Fatigue at Day 43   [ Time Frame: 43 days ]

2.  Secondary:   Change From Baseline in Quality of Life at Days 22, 43 and 56   [ Time Frame: baseline, day 22, day 43, and day 56 ]

3.  Secondary:   Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment   [ Time Frame: 56 days ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Eudocia Quant Lee, MD
Organization: Dana-Farber Cancer Insitute
phone: 617-632-2166

Responsible Party: Eudocia Quant Lee, MD, Dana-Farber/Brigham and Women's Cancer Center Identifier: NCT00766467     History of Changes
Other Study ID Numbers: 07-341
First Submitted: October 2, 2008
First Posted: October 6, 2008
Results First Submitted: March 4, 2016
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016