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

Phase 3 Completed 254 enrolled Cephalon

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2004-03
Primary completion: —
Completion: 2004-12

Outcome

Met primary endpoint

registry MEAN Armodafinil 150 mg/Day: 3.1 (Standard Deviation 4.46) Minutes MEAN Placebo: 0.4 (Standard Deviation 2.87) Minutes NCT00080288 ↗

registry Armodafinil 150 mg/Day vs Placebo; p <0.0001; Mean Difference (Final Values) 2.7 (95% CI 1.67 to 3.69); ANCOVA NCT00080288 ↗

Publications

Czeisler CA, Walsh JK, Wesnes KA, Arora S, Roth T. Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study. Mayo Clin Proc. 2009 Nov;84(11):958-72. doi: 10.1016/S0025-6196(11)60666-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Armodafinil	Small molecule	150 mg	—