At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years, any ethnic origin
- ✓Formal diagnosis of OSAHS per ICSD criteria
- ✓Excessive sleepiness despite effective nCPAP therapy
- ✓nCPAP effectiveness: AHI ≤10 on PSG during stable therapy regimen (≥4 weeks)
- ✕Any clinically significant uncontrolled medical or psychiatric conditions
- ✕Current sleep disorder other than OSAHS
- ✕Caffeine consumption >600 mg/day
- ✕Known clinically significant drug sensitivity to stimulants or modafinil
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 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 150 mg/day and Placebo for Obstructive Sleep Apnea and Sleep Hypopnea. Completed, enrolled 263 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 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).
Study Details
Timeline
Interventions
Armodafinil 150 mg once daily in the morning
Matching placebo tablets once daily