Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
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
Outcome
Met primary endpoint
registry Armodafinil 150 mg/Day vs Placebo; p = 0.0003; Mean Difference (Final Values) 3.5 (95% CI 1.67 to 5.46) NCT00079677 ↗
registry Armodafinil 150 mg/Day vs Placebo; p = 0.0069; Cochran-Mantel-Haenszel NCT00079677 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Armodafinil | Small molecule | 150 mg | — |