Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

Launched by CEPHALON · Mar 3, 2010

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Eligibility criteria

• 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.