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

This study has been completed.
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
University of California, San Diego
Beth Israel Deaconess Medical Center
Cephalon
Information provided by (Responsible Party):
Eudocia Quant Lee, MD, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier:
NCT00766467
First received: October 2, 2008
Last updated: June 17, 2016
Last verified: June 2016
Results First Received: March 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Condition: Malignant Glioma
Interventions: Drug: Armodafinil
Other: Placebo

  Participant Flow
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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
  Description
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  
NOT COMPLETED     11     8  
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
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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
  Description
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  
Number of Participants  
[units: participants]
  42     39     81  
Age  
[units: years]
Median (Full Range)
  56  
  (25 to 79)  
  54  
  (19 to 78)  
  55  
  (19 to 79)  
Gender  
[units: participants]
     
Female     18     18     36  
Male     24     21     45  
Karnofsky Performance Status (KPS) [1]
[units: Units on a scale]
Median (Full Range)
  90  
  (70 to 100)  
  90  
  (70 to 100)  
  90  
  (70 to 100)  
Glioma grade [2]
[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] 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.
[2] 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
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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
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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
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  More Information
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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
e-mail: eqlee@partners.org



Responsible Party: Eudocia Quant Lee, MD, Dana-Farber/Brigham and Women's Cancer Center
ClinicalTrials.gov Identifier: NCT00766467     History of Changes
Other Study ID Numbers: 07-341
Study First Received: October 2, 2008
Results First Received: March 4, 2016
Last Updated: June 17, 2016
Health Authority: United States: Institutional Review Board