At a glance
ClinicalIndex Comparison Record- ✓Men and women aged 18-65 years at start of prior double-blind study
- ✓Completed a cephalon-sponsored armodafinil double-blind study (C10953/3020/NA/MN, C10953/3021/AP/MN, C10953/3022/CM/MN, or C10953/3025/AP/MN) with investigator recommendation for enrollment
- ✓OSAHS patients must continue regular nCPAP therapy deemed effective by investigator
- ✓SWSD patients must work ≥5 nights/month with night shifts of 6-12 hours between 22:00-08:00
- ✕Any clinically significant uncontrolled medical condition
- ✕Current sleep disorder other than narcolepsy, OSAHS, or chronic SWSD
- ✕Caffeine consumption averaging >600 mg/day
- ✕Use of disallowed prescription drugs or clinically significant OTC drug use within 7 days before visit 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Month, Open-Label, Flexible-Dosage (100 to 250 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil (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 Armodafinil 100 to 250 mg/day for Excessive Daytime Sleepiness and 3 related conditions. Completed, enrolled 743 participants across 100 sites in 7 countries.
Detailed Summary
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
Study Details
Timeline
Interventions
Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).