NCT00079677

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

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 (150 mg/Day) as Treatment for Adults With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (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 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).

Conditions

• Obstructive Sleep Apnea
• Sleep Hypopnea

Interventions

Type	Name	Description
DRUG	Armodafinil 150 mg/day	Armodafinil 150 mg once daily in the morning
DRUG	Placebo	Matching placebo tablets once daily

Timeline

• Start date: 2004-03-01
• Completion: 2004-10-01
• First posted: 2004-03-12
• Last updated: 2013-07-19
• Results posted: 2010-02-03