Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder

Phase 3 Completed 427 enrolled Cephalon

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag disorder.

Timeline

Start: 2008-09
Primary completion: 2009-02
Completion: 2009-02

Outcome

Mixed primary results

registry analysis (superiority or other test); Armodafinil 50 mg/Day vs Placebo; p <0.0001; Mean Difference (Final Values) 2.9 (95% CI 2.07 to 3.71); ANCOVA NCT00758498 ↗

registry analysis (superiority or other test); Armodafinil 150 mg/Day vs Placebo; p <0.0001; Mean Difference (Final Values) 6.9 (95% CI 6.06 to 7.69); ANCOVA NCT00758498 ↗

registry analysis (superiority or other test); Armodafinil 50 mg/Day vs Placebo; p = 0.8341; Mean Difference (Final Values) 0.0 (95% CI -0.20 to 0.25); ANOVA NCT00758498 ↗

registry analysis (superiority or other test); Armodafinil 150 mg/Day vs Placebo; p = 0.0441; Mean Difference (Final Values) -0.3 (95% CI -0.50 to -0.05); ANCOVA NCT00758498 ↗

Publications

Rosenberg RP, Bogan RK, Tiller JM, Yang R, Youakim JM, Earl CQ, Roth T. A phase 3, double-blind, randomized, placebo-controlled study of armodafinil for excessive sleepiness associated with jet lag disorder. Mayo Clin Proc. 2010 Jul;85(7):630-8. doi: 10.4065/mcp.2009.0778. Epub 2010 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Armodafinil	Small molecule	50 mg	Oral
Subject	Armodafinil	Small molecule	150 mg	Oral