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Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients

This study has been terminated.
(Slow Enrollment)
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01169753
First received: July 23, 2010
Last updated: November 4, 2015
Last verified: November 2015
Results First Received: November 4, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Chronic Myeloid Leukemia
Interventions: Drug: Placebo
Drug: Armodafinil

  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
Recruitment Period: May 12, 2011 to December 4, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated early due to slow accrual.

Reporting Groups
  Description
Placebo Oral placebo every morning for 2 weeks.
Armodafinil Armodafinil Three 50 mg tablets orally every morning for 2 weeks.

Participant Flow:   Overall Study
    Placebo     Armodafinil  
STARTED     0     1  
COMPLETED     0     0  
NOT COMPLETED     0     1  



  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
Placebo Oral placebo every morning for 2 weeks.
Armodafinil Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Armodafinil     Total  
Number of Participants  
[units: participants]
  0     1     1  
Age  
[units: participants]
     
<=18 years         0     0  
Between 18 and 65 years         1     1  
>=65 years         0     0  
Gender  
[units: participants]
     
Female         1     1  
Male         0     0  
Region of Enrollment  
[units: participants]
     
United States         1     1  



  Outcome Measures

1.  Primary:   Number of Participants With "Fatigue Worst" BFI Score   [ Time Frame: After each 2 week treatment ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carmen Escalante, MD / Chair, General Internal Medicine
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01169753     History of Changes
Other Study ID Numbers: 2009-0638
NCI-2011-00895 ( Registry Identifier: NCI CTRP )
Study First Received: July 23, 2010
Results First Received: November 4, 2015
Last Updated: November 4, 2015
Health Authority: United States: Food and Drug Administration