Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Completed
Cephalon
Phase 3
2004-01-01
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).
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
Completed
Cephalon
Phase 3
2004-02-01
The primary objective of this study is to determine whether treatment with Armodafinil
(CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness
associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep
latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps
at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings
(as related to general condition) at week 12, or last post-baseline visit.
Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy
Completed
Cephalon
Phase 3
2004-03-01
The primary objective of this study is to determine whether treatment with Armodafinil
(CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness
associated with narcolepsy by measuring mean sleep latency from the Maintenance of
Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500)
and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general
condition) at week 12 (or last postbaseline observation)
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