drugset / Trial / NCT00079677

Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome

NCT00079677

Phase 3 Completed 263 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 residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).

Timeline

Start
2004-03
Primary completion
Completion
2004-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Armodafinil Small molecule 150 mg