Clinical Trials Logo
  1. Home
  2. Shift-Work Sleep Disorder
  3. NCT00078312

Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Sleep Apnea, Obstructive Clinical Trial

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)

Clinical Trial Summary

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).

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00078312
Study type Interventional
Source Teva Pharmaceutical Industries
Contact
Status Completed
Phase Phase 3
Start date January 2004
Completion date July 2006
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT04912635 - Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo N/A
Not yet recruiting NCT05939934 - Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal N/A
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Terminated NCT02269774 - Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea N/A
Completed NCT02088723 - Testing the Elevation as Sleep Apnea Treatment N/A
Completed NCT02261857 - 3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea Early Phase 1
Completed NCT01181570 - Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea Phase 4
Completed NCT01943708 - Novel Auto-continuous Positive Airway Pressure (CPAP) Validation Phase 3
Completed NCT00273754 - The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). Phase 2
Recruiting NCT02166879 - Undetected Sleep Apnea in the Postanesthesia Acute Care Unit (PACU)
Recruiting NCT04963192 - Integrated Management of Chronic Respiratory Diseases N/A
Completed NCT04846400 - Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia N/A
Completed NCT05056766 - How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
Recruiting NCT04314492 - Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults N/A
Completed NCT05175287 - OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Active, not recruiting NCT03431038 - Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH N/A
Enrolling by invitation NCT03075787 - Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea N/A
Completed NCT03300037 - HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor N/A
Recruiting NCT06097949 - AcuPebble to Remotely Monitor Patients With OSA on CPAP Therapy