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Trial record 37 of 239 for:    (armodafinil)

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

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.
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
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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
Enrollment 1
Recruitment Details 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 Study terminated early due to slow accrual.
Arm/Group Title Placebo Armodafinil
Hide Arm/Group Description Oral placebo every morning for 2 weeks. Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
Period Title: Overall Study
Started 0 1
Completed 0 0
Not Completed 0 1
Arm/Group Title Placebo Armodafinil Total
Hide Arm/Group Description Oral placebo every morning for 2 weeks. Armodafinil Three 50 mg tablets orally every morning for 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 0 1 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
<=18 years 0 0
Between 18 and 65 years 1 1
>=65 years 0 0
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 1 participants 1 participants
Female 1 1
Male 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 1 participants 1 participants
1 1
1.Primary Outcome
Title Number of Participants With "Fatigue Worst" BFI Score
Hide Description Efficacy defined by "fatigue worst" score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue.
Time Frame After each 2 week treatment
Hide Outcome Measure Data
Hide Analysis Population Description
No analysis completed, study stopped due to slow accrual with only one participant.
Arm/Group Title Placebo Armodafinil
Hide Arm/Group Description:
Oral placebo every morning for 2 weeks.
Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Armodafinil
Hide Arm/Group Description Oral placebo every morning for 2 weeks. Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
All-Cause Mortality
Placebo Armodafinil
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Armodafinil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Armodafinil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      1/1 (100.00%)    
Gastrointestinal disorders     
Decreased appetite  1  0/0  0 1/1 (100.00%)  1
General disorders     
Insomnia  1  0/0  0 1/1 (100.00%)  1
Jittery feeling  1  0/0  0 1/1 (100.00%)  1
Investigations     
Heart racing  1  0/0  0 1/1 (100.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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