At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 65 years
- ✓Complaint of excessive sleepiness despite effective and regular nCPAP use
- ✓Current OSAHS diagnosis per ICSD criteria
- ✓nCPAP effective with AHI ≤10 on PSG
- ✕Clinically significant uncontrolled medical or psychiatric conditions
- ✕Probable diagnosis of sleep disorder other than OSAHS
- ✕Known clinically significant drug sensitivity to stimulants or modafinil
- ✕History of alcohol, narcotic, or other drug abuse per DSM-IV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Armodafinil 250 mg/day, Armodafinil 150 mg/day, and 1 other intervention for Obstructive Sleep Apnea and Hypopnea. Completed, enrolled 395 participants.
Detailed 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.
Study Details
Timeline
Interventions
Armodafinil 250 mg once daily in the morning
Armodafinil 150 mg once daily in the morning
Matching placebo tablets once daily in the morning