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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. The patient currently meets the criteria for Shift Work Disorder (SWD) for duration
of at least 1 month.
2. The patient has the presence of excessive sleepiness late in the shift, including the
commute home if applicable, with a Clinical Global Impression of Severity of Illness
(CGI-S) rating of 4 or more at screening.
3. The patient has clinically significant difficulty in social or occupational
functioning, with a Global Assessment of Function (GAF) score less than 70 (on
clinician interview) at screening.
4. The patient has a Karolinska Sleepiness Scale (KSS) score of 6 or more at screening
(visit 1) that is confirmed at baseline (visit 2).
5. The patient works at least 5 night shifts per month, of which at least 3 nights are
consecutive, and plans to maintain this schedule.
6. The patient works night shifts or rotating shifts that include at least 6 hours
between 2200 and 0800 (including the time period 0400 to 0800), and shifts are no
longer than 12 hours in duration.
7. The patient is in good health, as judged by the investigator.
8. The patient is able to complete self-rating scales.
9. Women of childbearing potential (not surgically sterile or 2 years postmenopausal),
must use a medically accepted method of contraception, and must continue use of 1 of
these methods for the duration of the study (and for 30 days after participation in
the study). Acceptable methods of contraception include: abstinence, barrier method
with spermicide, steroidal contraceptive (oral, transdermal, implanted, and injected)
in conjunction with a barrier method, or intrauterine device (IUD).
10. The patient is willing and able to comply with study restrictions and to attend
regularly scheduled clinic visits as specified in this protocol
Exclusion Criteria:
1. The patient has mild or more severe obstructive sleep apnea (OSA) defined as an
apnea/hypopnea index more than 5 as determined by daytime polysomnography (PSG).
2. The patient has a medical or psychiatric disorder causing clinically significant
functional impairment or contributing to the patient's excessive sleepiness.
3. The patient is currently taking a medication or substance that is causing clinically
significant functional impairment or contributing to the patient's excessive
sleepiness.
4. The patient has a clinically significant treated or untreated medical condition.
5. The patient has a history of clinically significant suicidal ideation in the judgment
of the principal investigator or is currently suicidal based on medical and
psychiatric history.
6. The patient has a known hypersensitivity to armodafinil, racemic modafinil, or any
component of the study drug tablets.
7. The patient has a history of any clinically significant cutaneous drug reaction, or a
history of clinically significant hypersensitivity reaction, including multiple
allergies or drug reactions.
8. The patient consumes caffeine including coffee, tea and/or other caffeine containing
beverages or food averaging more than 600 mg of caffeine per day within 7 days of the
baseline visit.
9. The patient uses any prescription or over-the-counter (OTC) drugs disallowed by the
protocol within 30 days of the baseline visit.
10. The patient has been in a prior armodafinil study.
11. The patient has a history of alcohol, narcotic, or any other drug abuse.
12. The patient has a positive urine drug screen (UDS) without medical explanation at the
screening visit.
13. The patient has a clinically significant deviation from normal on physical
examination.
14. The patient is a pregnant or lactating woman.
15. The patient has used an investigational drug within 1 month of the screening visit.
16. The patient has a disorder that could interfere with the absorption, distribution,
metabolism, or excretion of the investigational product.
17. The patient needs to use any of the excluded medications in this protocol.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Secondary Outcome(s)
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Change From Baseline to Endpoint in Global Assessment of Function (GAF) Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Activity Level Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) General Productivity Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Intimacy
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Social Outcome
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Total Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) Vigilance Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Mean Karolinska Sleepiness Scale (KSS) Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Composite Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Family Life Item Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Days Missed Work or Unable to Carry Out Responsibilities
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Score - Number of Days of Reduced Productivity
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Social Life Item Score
[Time Frame: Baseline and week 6 (or last observation (or last observation after baseline))]
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Change From Baseline to Endpoint in the Modified Sheehan Disability Scale (MSDS) Work Item Score
[Time Frame: Baseline and week 6 (or last observation after baseline)]
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Change From Baseline to Week 3 in Global Assessment of Functioning
[Time Frame: Baseline and Week 3]
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Change From Baseline to Week 3 in the Mean Karolinska Sleepiness Scale (KSS) Score
[Time Frame: Baseline and week 3]
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Change From Baseline to Week 6 in Global Assessment of Functioning
[Time Frame: Baseline and Week 6]
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Change From Baseline to Week 6 in the Mean Karolinska Sleepiness Scale (KSS) Score
[Time Frame: Baseline and week 6]
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Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 3
[Time Frame: Baseline and week 3]
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Percentage of Patients With at Least Minimal Improvement From Baseline in the Clinical Global Impression of Change (CGI-C) Rating as Related to Late Shift Sleepiness at Week 6
[Time Frame: Baseline and week 6]
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Treatment Satisfaction Questionnaire for Medication (TSQM)- Convenience Score at Endpoint
[Time Frame: Endpoint]
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Treatment Satisfaction Questionnaire for Medication (TSQM)- Effectiveness Score at Endpoint
[Time Frame: Endpoint]
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Treatment Satisfaction Questionnaire for Medication (TSQM)- Global Satisfaction Score at Endpoint
[Time Frame: Endpoint]
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Treatment Satisfaction Questionnaire for Medication (TSQM)- Side Effects Score at Endpoint
[Time Frame: Endpoint]
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