At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years, male or female, any ethnic origin
- ✓Excessive sleepiness associated with narcolepsy (diagnosed per ICSD criteria)
- ✓Excessive sleepiness associated with OSAHS (diagnosed per ICSD criteria, with stable nCPAP therapy for ≥4 weeks and documented regular usage ≥4 hours/night on ≥70% of nights)
- ✓Excessive sleepiness associated with chronic SWSD (diagnosed per ICSD criteria, with night shift work ≥3 months, ≥3 night shifts/month, 6–12 hours duration, planned continuation throughout study)
- ✕Any clinically significant uncontrolled medical conditions (treated or untreated)
- ✕Probable diagnosis of sleep disorder other than narcolepsy, OSAHS, or chronic SWSD
- ✕Caffeine consumption >600 mg/day or >8 cups coffee/day
- ✕Prescription drugs disallowed by protocol or clinically significant OTC drug use within 7 days before baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder (With an Open-Ended Extension Period)
In Brief
A Phase 3 clinical trial evaluating CEP-10953 (Armodafinil) for Narcolepsy and 3 related conditions. Completed, enrolled 328 participants across 50 sites in 2 countries.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure \[nCPAP\] therapy), or chronic shift work sleep disorder (SWSD).
Study Details
Timeline
Interventions
Armodafinil (po) 100 to 250 mg/day up to 12 months