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Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder

NCT00080288•Cephalon

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients are included in the study if all of the following criteria are met:
•Written informed consent is obtained.
•The patient is an outpatient, man or woman of any ethnic origin, 18 to 65 years of age (inclusive).
•The patient has a complaint of excessive sleepiness.
•The patient has a diagnosis of SWSD according to International Classification of Sleep Disorders (ICSD) criteria, and must have had excessive sleepiness during night shifts for at least 3 months.
•The patient must work at least 5 night shifts per month, of which at least 3 nights are consecutive, and plan to maintain this schedule.
•The patient must work night shifts that include at least 6 hours between 2200 and 0800 and be no longer than 12 hours in duration.
•The patient is in good health as determined by a medical and psychiatric history, physical examination, ECG, and serum chemistry and hematology.
•Women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, using a medically accepted method of birth control (ie, barrier method with spermicide, steroidal contraceptive, or intrauterine device \[IUD\]) and agree to continued use of this method for the duration of the study. Steroidal contraceptives must be used with a barrier method while taking the study drug and for at least a full cycle after discontinuation of the study drug.
•The patient has a mean sleep latency of 6 minutes or less as determined by the MSLT
+4 more criteria

Exclusion Criteria

•Patients are excluded from participating in this study if 1 or more of the following criteria are met:
•has any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
•has a probable diagnosis of a current sleep disorder other than SWSD
•consumes caffeine including coffee, tea and/or other caffeine containing beverages or food averaging more than 600 mg of caffeine per day
•used any prescription drugs disallowed by the protocol or clinically significant use of over the-counter (OTC) drugs within 7 days before the screening/baseline visit
•has a history of alcohol, narcotic, or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM IV)
•has a positive urine drug screen (UDS) at the screening visit
•has a clinically significant deviation from normal in the physical examination
•is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
•has used an investigational drug within 1 month before the screening visit
+2 more criteria

Key Dates

Start Date

March 1, 2004

Completion Date

December 1, 2004

Last Updated

July 19, 2013

Enrollment

254

ACTUAL participants

Conditions

Excessive SleepinessShift Work Sleep Disorder

Interventions

Armodafinil 150 mg/day

DRUG

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: July 19, 2013Data 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.

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

Inclusion Criteria

Exclusion Criteria

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