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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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).

Detailed Summary:
Sponsor: Cephalon

Current Primary Outcome: Safety and Tolerability as Measured by Number of Participants With Adverse Events [ Time Frame: Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter ]

Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Teva Pharmaceutical Industries

Dates:
Date Received: February 23, 2004
Date Started: January 2004
Date Completion:
Last Updated: July 12, 2013
Last Verified: July 2013