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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT01080807

Public ClinicalTrials.gov record NCT01080807. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 9:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01080807
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Cephalon
Industry
Enrollment
385 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 2010 (Type not available)
Primary completion
Oct 2010 (Actual)
Completion
Oct 2010 (Actual)
Last update posted
Jun 20, 2012

2010

United States locations

U.S. sites
63
U.S. states
26
U.S. cities
59
Facility City State ZIP Site status
REM Medical Sleep Center Phoenix Arizona 85037 —
REM Medical Clinical Research Tucson Arizona 85712 —
Central Arkansas Research Hot Springs Arkansas 71913 —
Clinical Study Centers LLC Little Rock Arkansas 72205 —
Peninsula Sleep Center Burlingame California 94010 —
Avastra Clinical Trials Fountain Valley California 92708 —
Pacific Sleep Medicine Services Inc Los Angeles California 90048 —
Southwestern Research Inc Pasadena California 91106 —
Pacific Sleep Medicnie Services Inc Redlands California 92373 —
Stanford University Medical Center Redwood City California 94063 —
Dormir Clinical Trials, Inc. San Diego California 92121 —
Southwestern Research Inc Santa Ana California 92705 —
St Johns Medical Plaza Sleep Disorders Center Santa Monica California 90404 —
PAB Clinical Research Brandon Florida 33511 —
MD Clinical Hallandale Florida 33009 —
Compass Research LLC Orlando Florida 32806 —
Broward Research Group Pembroke Pines Florida 33026 —
Miami Research Associates South Miami Florida 33143 —
Florida Sleep Institute Spring Hill Florida 34609 —
Clinical Research Group of St Petersburg St. Petersburg Florida 33707 —
SomnoMedics Tampa Florida 33607 —
Neurotrials Research Inc Atlanta Georgia 30342 —
Sleep Disorders Center of Georgia-Peachtree Atlanta Georgia 30342 —
Sleep Disorders Center of Georgia-Gainesville Gainesville Georgia 30501 —
Sleepmed Inc Macon Georgia 31201 —
Chicago Research Center Chicago Illinois 60634 —
Suburban Lung Associates Elk Grove Village Illinois 60007 —
The Center for Sleep and Wake Disorders d/b/a Midwest Neuro Danville Indiana 46122 —
Fort Wayne Neurological Center Fort Wayne Indiana 46804 —
Rehabilitation Associates of Indiana Indianapolis Indiana 46250 —
Goldpoint Clinical Research Indianapolis Indiana 46260 —
University of Iowa Hospitals Iowa City Iowa 52242 —
Vince and Associates Clinical Research Overland Park Kansas 66212 —
Community Research Crestview Kentucky 41017 —
Kentucky Research Group Louisville Kentucky 40217 —
Helene A. Emsellem, MD Chevy Chase Maryland 20815 —
Sleep Health Center Brighton Massachusetts 02135 —
St Mary's of Michigan Saginaw Michigan 48604 —
The Center for Sleep Medicine Hattiesburg Mississippi 39402 —
Washington University Sleep Medicine Center St Louis Missouri 63108 —
Clayton Sleep Institute LLC St Louis Missouri 63143 —
Somnos Laboratories, Inc d/b/a Somnos Clinical Research Lincoln Nebraska 68510 —
Clinical Research Center of Nevada Las Vegas Nevada 89104 —
CliniLabs Inc New York New York 10019 —
Duke Insomnia & Sleep Research Program Durham North Carolina 27710 —
Wake Research Associates Raleigh North Carolina 27612 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —
North Coast Clinical Trials Inc Beachwood Ohio 44122 —
Community Research Inc Cincinnati Ohio 45227 —
Tri State Sleep Disorders Center Cincinnati Ohio 45246 —
North Star Medical Research LLC Middleburg Heights Ohio 44130 —
Mercy St Anne Sleep Disorder Center Toledo Ohio 43623 —
Lynn Health Science Institute Oklahoma City Oklahoma 73112 —
Southeastern PA Medical Institute Broomall Pennsylvania 19008 —
Consolidated Clinical Trials Jefferson Hills Pennsylvania 15025 —
CRI Worldwide Philadelphia Pennsylvania 19139 —
Sleep Lab of Northeastern PA Summit Hill Pennsylvania 18411 —
SleepMed of South Carolina Columbia South Carolina 29201 —
Mid-South Neurology Center Germantown Tennessee 38139 —
FutureSearch Trials of Neurology Austin Texas 78756 —
Kingwood Research Institute Kingwood Texas 77339 —
Sleep Therapy and Research Center San Antonio Texas 78250 —
Avastra Clinical Trials Midvale Utah 84047 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01080807, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 20, 2012 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01080807 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →