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Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Armodafinil Treatment (150 mg) in Improving Clinical Condition Late in the Shift and in Improving Functional and Patient-Reported Outcomes in Adult Patients With Excessive Sleepiness Associated With Shift Work Disorder

NCT01080807•Cephalon

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

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.
+7 more criteria

Locations (63)

REM Medical Sleep Center

Phoenix, Arizona, United States

REM Medical Clinical Research

Tucson, Arizona, United States

Central Arkansas Research

Hot Springs, Arkansas, United States

Clinical Study Centers LLC

Little Rock, Arkansas, United States

Peninsula Sleep Center

Burlingame, California, United States

Avastra Clinical Trials

Fountain Valley, California, United States

Pacific Sleep Medicine Services Inc

Los Angeles, California, United States

Southwestern Research Inc

Pasadena, California, United States

Pacific Sleep Medicnie Services Inc

Redlands, California, United States

Stanford University Medical Center

Redwood City, California, United States

Key Dates

Start Date

March 1, 2010

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

June 20, 2012

Enrollment

385

ACTUAL participants

Conditions

Excessive Sleepiness

Interventions

Armodafinil

DRUG

Matching Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Safety and Tolerability of Single and Multiple Ascending Doses of GATE-101 in Normal Human Volunteers

A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness

Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

Palliative Morphine With or Without Concurrent Modafinil