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 ]
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