Trials / Completed
CompletedNCT00078325
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)
A 12 Week, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CEP 10953 (150 and 250 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
- 395 (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 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 post-baseline visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Armodafinil 250 mg/day | Armodafinil 250 mg once daily in the morning |
| DRUG | Armodafinil 150 mg/day | Armodafinil 150 mg once daily in the morning |
| DRUG | Placebo | Matching placebo tablets once daily in the morning |
Timeline
- Start date
- 2004-02-01
- Primary completion
- 2004-11-01
- Completion
- 2004-11-01
- First posted
- 2004-02-25
- Last updated
- 2013-07-19
- Results posted
- 2010-07-29
Source: ClinicalTrials.gov record NCT00078325. Inclusion in this directory is not an endorsement.