Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Public ClinicalTrials.gov record NCT00078312. 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.
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) Study of the Safety and Efficacy of 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.
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).
Study identification
- NCT ID
- NCT00078312
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 328 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
- Jan 2004 (Type not available)
- Primary completion
- Jul 2006 (Actual)
- Completion
- Jul 2006 (Actual)
- Last update posted
- Jul 19, 2013
2004 – 2006
United States locations
- U.S. sites
- 41
- U.S. states
- 24
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pivotal Research Centers | Peoria | Arizona | 85381 | — |
| Central Phoenix Medical Clinic, LLC | Phoenix | Arizona | 85014 | — |
| Radiant Research - Tucson | Tucson | Arizona | 85710 | — |
| Central Arkansas Research | Hot Springs | Arkansas | 71913 | — |
| Arkansas Center for Sleep Medicine | Little Rock | Arkansas | 72205 | — |
| Bay Area Research Institute | Lafayette | California | 94549 | — |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | — |
| Neuro-Therapeutics Inc. | Pasadena | California | 91105 | — |
| Anderson Clinical Research | Redlands | California | 92374 | — |
| Synergy Clinical Research Center | San Diego | California | 92105 | — |
| BMR HealthQuest Clinical Trials | San Diego | California | 92123 | — |
| Rocky Mountain Center for Clinical Research | Wheat Ridge | Colorado | 80033 | — |
| Therafirst Medical Centers | Fort Lauderdale | Florida | 33308 | — |
| Precision Research | Hallandale | Florida | 33009 | — |
| Renstar Medical Research | Ocala | Florida | 34471 | — |
| Clinical Research Group of St. Petersburg | St. Petersburg | Florida | 33707 | — |
| Radiant Research, Boise | Boise | Idaho | 83704 | — |
| Herron Medical Center, Ltd. | Chicago | Illinois | 60610 | — |
| Radiant Research, Chicago | Chicago | Illinois | 60610 | — |
| Radiant Research Alexian Brothers | Elk Grove Village | Illinois | 60007 | — |
| Henry W. Lahmeyer, MD and Associates | Northfield | Illinois | 60093 | — |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66211 | — |
| NeuroTrials Research of New Orleans, LLC | Metairie | Louisiana | 70001 | — |
| Marc Raphaelson, MD, PA | Frederick | Maryland | 21702 | — |
| Michigan Head-Pain Neurological Institute | Ann Arbor | Michigan | 48104 | — |
| Somnos Laboratories, Inc | Lincoln | Nebraska | 68510 | — |
| Clinical Research Center of Nevada | Las Vegas | Nevada | 89104 | — |
| CNS Research Institute, PC | Clementon | New Jersey | 08021 | — |
| Long Island Clinical Research Associates, LLP | Great Neck | New York | 11021 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| North Coast Clinical Trials, Inc | Beachwood | Ohio | 44122 | — |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Clinical Research Studies | Oklahoma City | Oklahoma | 73109 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Lehigh Valley Hospital Hospital | Allentown | Pennsylvania | 18105 | — |
| Center for Sleep Disorders, Inc. | Pottstown | Pennsylvania | 19464 | — |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | — |
| Radiant Research, San Antonio | San Antonio | Texas | 78229 | — |
| Radiant Research | Salt Lake City | Utah | 84107 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | — |
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 9 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00078312, 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 NCT00078312 live on ClinicalTrials.gov.