Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder
Condition: Excessive Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Intervention: Armodafinil; Matching Placebo
Intervention description: At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.; At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
Intervention MeSH terms: Modafinil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 385.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

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.