At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 65 years
- ✓Diagnosis of narcolepsy according to ICSD criteria
- ✓Complaint of excessive sleepiness
- ✓Mean sleep latency ≤6 minutes on Multiple Sleep Latency Test (MSLT)
- ✕Uncontrolled medical or psychiatric conditions
- ✕Other sleep disorders besides narcolepsy
- ✕Excessive caffeine consumption (>600 mg/day)
- ✕Prescription or OTC drug use within 7 days before second screening visit (unless protocol-allowed)
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 Excessive Sleepiness Associated With Narcolepsy
In Brief
A Phase 3 clinical trial evaluating Armodafinil and Placebo for Narcolepsy. Completed, enrolled 196 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 narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)
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