NCT00078377

Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 and 250 mg/Day) as Treatment for Adults With Excessive Sleepiness Associated With Narcolepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Narcolepsy

Interventions

Type	Name	Description
DRUG	Armodafinil	Armodafinil 250 mg once daily in the morning
DRUG	Armodafinil	Armodafinil 150 mg once daily in the morning
DRUG	Placebo	Matching placebo tablets once daily

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2004-02-26
• Last updated: 2013-07-19
• Results posted: 2010-01-21