NCT00080288

Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 mg) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (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 chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.

Conditions

• Excessive Sleepiness
• Shift Work Sleep Disorder

Interventions

Type	Name	Description
DRUG	Armodafinil 150 mg/day	Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.
DRUG	Placebo	Matching placebo tablets once daily

Timeline

• Start date: 2004-03-01
• Completion: 2004-12-01
• First posted: 2004-03-29
• Last updated: 2013-07-19
• Results posted: 2009-09-23