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

Cephalon

Status and phase: Completed; Phase 4

Conditions: Excessive Sleepiness

Treatments: Drug: Matching Placebo; Drug: Armodafinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01080807

C10953/4030

Details and patient eligibility

About

The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with shift work disorder (SWD) by measuring improved clinical condition late in the shift, including the commute home.

Enrollment: 385 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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385 participants in 2 patient groups, including a placebo group

150 mg/day armodafinil

Experimental group

Treatment:

Drug: Armodafinil

Matching placebo

Placebo Comparator group

Treatment:

Drug: Matching Placebo