drugset / Trial / NCT00078377

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

NCT00078377

Phase 3 Completed 196 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 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)

Timeline

Start
2004-03
Primary completion
2005-01
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Armodafinil Small molecule 150 mg
Subject Armodafinil Small molecule 250 mg

Indications