Conditions: Narcolepsy
Keywords: Narcolepsy Excessive Sleepiness Cataplexy Sleep Attacks Excessive Sleepiness associated with Narcolepsy Cephalon Cephalon, Inc Nuvigil
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 196
Healthy volunteers: no

Brief summary:
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)

Detailed description:

Arms:
arm 1: Armodafinil 250 mg arm 2: Armodafinil 150 mg arm 3: Placebo

Interventions: intervention 1: Armodafinil intervention 2: Armodafinil intervention 3: Placebo
Intervention descriptions: intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily

Protocol document: