At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 65 years (inclusive)
- ✓Diagnosed with Shift Work Sleep Disorder per ICSD criteria with excessive sleepiness during night shifts for at least 3 months
- ✓Works at least 5 night shifts per month, of which at least 3 are consecutive, with planned continuation of this schedule
- ✓Works night shifts of 6–12 hours including at least 6 hours between 2200 and 0800
- ✕Any clinically significant uncontrolled medical or psychiatric condition
- ✕Other active sleep disorder besides SWSD
- ✕Caffeine consumption exceeding 600 mg per day
- ✕Recent use of disallowed prescription drugs or clinically significant OTC drugs within 7 days
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) as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder
In Brief
A Phase 3 clinical trial evaluating Armodafinil 150 mg/day and Placebo for Excessive Sleepiness and Shift Work Sleep Disorder. Completed, enrolled 254 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 chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.
Study Details
Timeline
Interventions
Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked.
Matching placebo tablets once daily