NCT00078312

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 328 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Narcolepsy
• Sleep Apnea, Obstructive
• Sleep Apnea Syndromes
• Shift-Work Sleep Disorder

Interventions

Type	Name	Description
DRUG	CEP-10953 (Armodafinil)	Armodafinil (po) 100 to 250 mg/day up to 12 months

Timeline

• Start date: 2004-01-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2004-02-25
• Last updated: 2013-07-19
• Results posted: 2010-02-22

Locations

50 sites across 2 countries: United States, Russia