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Completed Phase 3 Interventional Results available

Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness

ClinicalTrials.gov ID: NCT00228553

Public ClinicalTrials.gov record NCT00228553. 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, 8:03 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 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)

Brief summary

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

A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Study identification

NCT ID
NCT00228553
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Cephalon
Industry
Enrollment
743 participants

Conditions and interventions

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
May 2004 (Type not available)
Primary completion
Not listed
Completion
Jul 2006 (Actual)
Last update posted
Jul 19, 2013

2004 – 2006

United States locations

U.S. sites
74
U.S. states
32
U.S. cities
67
Facility City State ZIP Site status
Sleep Disorders Ctr of Alabama Birmingham Alabama 35213 —
Pulmonary Associates, PA Phoenix Arizona 85006 —
Psypharma Clinical Research Phoenix Arizona 85050 —
Central Arkansas Research Hot Springs Arkansas 71913 —
Advanced Clinical Research Ins Anaheim California 92801 —
Southwestern Research Beverly Hills California 90210 —
Pacific Sleep Medicine Service Los Angeles California 90048 —
Pacific Sleep Medicine Service Palm Springs California 92262 —
Radiant Research San Diego San Diego California 92103 —
Pacific Sleep Medicine Service San Diego California 92121 —
BMR HealthQuest San Diego California 92123 —
Sleep Clinic of San Francisco San Francisco California 94117 —
St. Johns Medical Plaza Sleep Santa Monica California 90404 —
Stanford University Stanford California 94305 —
PAB Clinical Research Brandon Florida 33511 —
St. Petersburg Sleep Disorder St. Petersburg Florida 33707 —
Sleep-Wake Disorder Center Winter Park Florida 32789 —
Neurotrials Research Atlanta Georgia 30342 —
Sleep Disorders Center of GA Atlanta Georgia 30342 —
SLEEPMED, Inc. Macon Georgia 31202 —
Radiant Research Marietta Marietta Georgia 30060 —
Henry Lahmeyer, MD Northfield Illinois 60093 —
Peoria Pulmonary Associates Peoria Illinois 61603 —
Center for Sleep Disorders Danville Indiana 46122 —
University of Iowa Hospitals Iowa City Iowa 52242 —
Vince and Associates Clinical Overland Park Kansas 66211 —
Topeka Pulmonary Topeka Kansas 66606 —
Graves Gilbert Clinic Bowling Green Kentucky 42101 —
Community Research Crestview Kentucky 45217 —
Chest Medicine Associates DBA Louisville Kentucky 40217 —
Neurotrials Research of New Or Metairie Louisiana 70001 —
Northshore Research Associates Slidell Louisiana 70461 —
Center for Sleep/Wake Disorder Chevy Chase Maryland 20815 —
Regional Pulmonary and Sleep Elkton Maryland 21021 —
McLean Hospital Belmont Massachusetts 02478 —
Neurocare, Inc. Newton Massachusetts 02459 —
Sleep Disorders Center Hattiesburg Mississippi 39404 —
Washington University School o St Louis Missouri 63105 —
Clinical Rsch Center of Nevada Las Vegas Nevada 89104 —
CNS Research Institute Clementon New Jersey 08021 —
New York University New York New York 10016 —
Clinilabs / Sleep Disorders In New York New York 10025 —
Montefiore Medical Center The Bronx New York 10467 —
Duke University Hospital Durham North Carolina 27710 —
Vital re:Search Greensboro North Carolina 27408 —
Neurology Associates of Hickor Hickory North Carolina 28602 —
Wake Research Associates Raleigh North Carolina 27612 —
Central Carolina Neurology Sle Salisbury North Carolina 28144 —
All Trials Clinical Research Winston-Salem North Carolina — —
St. Alexius Medical Center Bismarck North Dakota 58501 —
North Coast Clinical Trials Beechwood Ohio 44122 —
Community Research Management Cincinnati Ohio 45219 —
Tri State Sleep Disorders Cent Cincinnati Ohio 45246 —
Cleveland Clinic Foundation Cleveland Ohio 44195 —
Dept Veterans Affairs Dayton Dayton Ohio 45428 —
Ohio Sleep Medicine-Neurosci Dublin Ohio 43017 —
Southwest Cleveland Sleep Cent Middleburg Heights Ohio 44130 —
St. Vincent Mercy Medical Cent Toledo Ohio 43608 —
Clinical Pharmaceutical Trials Tulsa Oklahoma 74104 —
Capital Region Sleep Disorders Carlisle Pennsylvania 17013 —
Consolidated Clinical Trials Pittsburgh Pennsylvania 15221 —
Omega Medical Research Warwick Rhode Island 02886 —
Lowcountry Lung and Critical Charleston South Carolina 29406 —
SleepMed of South Carolina Columbia South Carolina 29201 —
St. Thomas Sleep Disorders Cen Nashville Tennessee 37205 —
FutureSearch Trials Austin Texas 78703 —
Sleep Medicine Institute Dallas Texas — —
Houston Sleep Center Houston Texas 77024 —
VA Medical CenterSleep Diagnos Houston Texas 77030 —
Sadler Clinic The Woodlands Texas 77380 —
Radiant Research Salt Lake Salt Lake City Utah 84107 —
Sentara Norfolk General Hospit Norfolk Virginia 23507 —
Swedish Sleep Medicine Institute Seattle Washington 98122 —
Allegiance Research Specialist Wauwatosa Wisconsin 53226 —

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 26 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00228553, 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 Jul 19, 2013 · 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 NCT00228553 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →