|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00078312 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Narcolepsy Sleep Apnea, Obstructive Sleep Apnea Syndromes Shift-Work Sleep Disorder |
Drug: CEP-10953 (Armodafinil) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
| Enrollment: | 328 |
| Study Start Date: | January 2004 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients are included in the study if all of the following criteria are met:
The patient has a complaint of excessive sleepiness associated with a current diagnosis of:
OSAHS-Diagnosis made on the basis of ICSD criteria. Furthermore, patients with OSAHS must meet the following nCPAP therapy requirements:
Exclusion Criteria:
Patients are excluded from participating in this study if 1 or more of the following criteria are met:
Contacts and Locations
Show 50 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00078312 History of Changes |
| Other Study ID Numbers: | C10953/3023/ES/MN |
| Study First Received: | February 23, 2004 |
| Results First Received: | June 1, 2009 |
| Last Updated: | March 26, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Excessive Sleepiness Narcolepsy Cataplexy Sleep Attacks Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP |
Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cepahlon Cephalon, Inc Nuvigil |
|
Apnea Narcolepsy Sleep Apnea Syndromes Sleep Disorders Parasomnias Sleep Apnea, Obstructive Sleep Disorders, Circadian Rhythm Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Disorders of Excessive Somnolence Sleep Disorders, Intrinsic Dyssomnias |
Nervous System Diseases Mental Disorders Neurologic Manifestations Chronobiology Disorders Occupational Diseases Modafinil Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Neuroprotective Agents Protective Agents |