Trial Outcomes & Findings for Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia Patients (NCT NCT01169753)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

After each 2 week treatment

Results posted on

2015-12-08

Participant Flow

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

Study terminated early due to slow accrual.

Participant milestones

Participant milestones
Measure	Placebo Oral placebo every morning for 2 weeks.	Armodafinil Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Oral placebo every morning for 2 weeks.	Armodafinil n=1 Participants Armodafinil Three 50 mg tablets orally every morning for 2 weeks.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 participants n=7 Participants	1 participants n=5 Participants
Age, Categorical >=65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Gender Female	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Male	—	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: After each 2 week treatment

Population: No analysis completed, study stopped due to slow accrual with only one participant.

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.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Armodafinil

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Oral placebo every morning for 2 weeks.	Armodafinil n=1 participants at risk Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
Investigations Heart racing	— 0/0 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.	100.0% 1/1 • Number of events 1 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.
General disorders Insomnia	— 0/0 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.	100.0% 1/1 • Number of events 1 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.
General disorders Jittery feeling	— 0/0 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.	100.0% 1/1 • Number of events 1 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.
Gastrointestinal disorders Decreased appetite	— 0/0 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.	100.0% 1/1 • Number of events 1 • Adverse event reporting collected through week 5 of period two which includes 2 two-week treatment periods and one week for washout phase.

Additional Information

Carmen Escalante, MD / Chair, General Internal Medicine

University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place