Trial Outcomes & Findings for Effect of Nuvigil on Fatigue (NCT NCT01460628)

Last Updated: 2017-03-15

Results Overview

This is a widely used self-report instrument to determine differences in quality of life among menopausal women and to measure changes in their quality of life over time. Four domain scores are calculated from the 29-item instrument. The physical domain subscale has 16 questions and a range from 0-8 with higher scores indicating worse symptoms.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-03-15

Participant Flow

Participant milestones

Participant milestones
Measure	Armodafinil Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Armodafinil Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Overall Study Adverse Event	3
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Effect of Nuvigil on Fatigue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Armodafinil n=25 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Age, Continuous	53.8 years STANDARD_DEVIATION 5.13 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Armodafinil n=20 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Menopause Quality Of Life Questionnaire (MENQOL) Physical Domain Subscale	1.9 units on a scale Interval 1.3 to 2.7

PRIMARY outcome

Timeframe: 4 weeks

This is a widely used self-report instrument to assess the severity of fatigue and the impact of fatigue on daily functioning. This 9 item instrument yields a global fatigue score ranging from 0-10 with higher scores indicating worse symptoms. .

Outcome measures

Outcome measures
Measure	Armodafinil n=20 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Brief Fatigue Inventory (BFI)	2.2 units on a scale Interval 1.1 to 4.4

SECONDARY outcome

Timeframe: 4 weeks

This self-report scale is widely used as a subjective measure of sleepiness. This 8 item instrument yields a total score ranging from 0-24 with higher scores indicating worse symptoms.

Outcome measures

Outcome measures
Measure	Armodafinil n=20 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Epsworth Sleepiness Scale (ESS)	3.0 units on a scale Interval 1.0 to 5.5

SECONDARY outcome

Timeframe: 4 weeks

The Daily Vasomotor Symptom Diary consists of a 7-day scale on which the subject records the total number of hot flushes they experience on a daily basis. Weekly averages for a 24-hour period are calculated.

Outcome measures

Outcome measures
Measure	Armodafinil n=20 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Hot Flash Frequency (24-hr Period)	1.5 # of hot flashes Interval 0.4 to 2.4

SECONDARY outcome

Timeframe: 4 weeks

The SCL-10 anxiety subscale, developed from the refinement of the Hopkins Symptom Checklist (HSCL), consists of 10 questions focused on how much discomfort symptoms of anxiety (e.g. "nervousness or shaking inside") have caused in the past two weeks. Each question is answered on a scale from 0-4, and answers are averaged for a total score between 0-4 with higher scores indicating more anxiety.

Outcome measures

Outcome measures
Measure	Armodafinil n=20 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Symptom Checklist-10 Anxiety	0 units on a scale Interval 0.0 to 0.2

SECONDARY outcome

Timeframe: 4 weeks

The PHQ-9 is the self-administered form of the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used instrument designed to screen for psychiatric illnesses in primary-care settings. This 9-item instrument assesses mood, depressive symptoms, and suicidal ideation. The range of total scores is 0-27 with higher scores indicating worse symptoms. Generally, scores 5-9 indicate mild depression, 10-14 indicate moderate depression, and 15+ indicate moderately severe or severe depression.

Outcome measures

Outcome measures
Measure	Armodafinil n=20 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Patient Health Questionnaire-9 (PHQ-9)	3.0 units on a scale Interval 1.0 to 6.0

SECONDARY outcome

Timeframe: 4 weeks

This is a normed and validated measure of ADHD-related executive function impairments. The clinician administered scale measures five clusters of executive function including 1) organizing and activating for work, 2) sustaining attention and concentration, 3) sustaining alertness, effort, and processing speed, 4) managing affective interference, and 5) using working memory and accessing recall. The frequency and severity of each of the 40 items is rated on a scale of 0 to 3, with the total scores ranging from 0-120 and higher scores indicating worse symptoms.

Outcome measures

Outcome measures
Measure	Armodafinil n=20 Participants Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Brown Attention Deficit Disorder Scale (BADDS)	15.5 units on a scale Interval 5.5 to 25.0

Adverse Events

Armodafinil

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Armodafinil n=25 participants at risk Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
Nervous system disorders headache	12.0% 3/25 • Number of events 3
Cardiac disorders increased blood pressure or heartbeat	16.0% 4/25 • Number of events 4
Ear and labyrinth disorders dry mouth	12.0% 3/25 • Number of events 4
Musculoskeletal and connective tissue disorders jaw clenching	4.0% 1/25 • Number of events 2
Gastrointestinal disorders stomach ache/nausea/gas	28.0% 7/25 • Number of events 9
Respiratory, thoracic and mediastinal disorders upper respiratory symptoms	20.0% 5/25 • Number of events 7
Nervous system disorders sleep disruption	16.0% 4/25 • Number of events 5
Psychiatric disorders depression/anxiety	32.0% 8/25 • Number of events 9
Ear and labyrinth disorders dizziness	4.0% 1/25 • Number of events 1
Nervous system disorders jitteriness	4.0% 1/25 • Number of events 1
Gastrointestinal disorders constipation/diarrhea	16.0% 4/25 • Number of events 4
Skin and subcutaneous tissue disorders skin irritation	12.0% 3/25 • Number of events 3
Metabolism and nutrition disorders increased appetite	4.0% 1/25 • Number of events 1
Reproductive system and breast disorders spotting	4.0% 1/25 • Number of events 1
Nervous system disorders word recall	4.0% 1/25 • Number of events 1

Additional Information

Dr. Hadine Joffe

Brigham & Women's Hospital

Phone: 617-732-4906

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place