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

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ClinicalTrials.gov Identifier: NCT01169753
Recruitment Status : Terminated (Slow Enrollment)
First Posted : July 26, 2010
Results First Posted : December 8, 2015
Last Update Posted : December 8, 2015
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Chronic Myeloid Leukemia
Interventions: Drug: Placebo
Drug: Armodafinil

  Participant Flow

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
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 

  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.
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Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 0   1   1 
[Units: Participants]
<=18 years      0   0 
Between 18 and 65 years      1   1 
>=65 years      0   0 
[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

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

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 )
First Submitted: July 23, 2010
First Posted: July 26, 2010
Results First Submitted: November 4, 2015
Results First Posted: December 8, 2015
Last Update Posted: December 8, 2015