Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078377
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2004-02-24
Brief Title:
Safety and Efficacy Study of Armodafinil CEP-10953 in the Treatment of Excessive Sleepiness Associated With Narcolepsy
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A 12-Week Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Evaluate the Efficacy and Safety of CEP-10953 150 and 250 mgDay as Treatment for Adults With Excessive Sleepiness Associated With Narcolepsy
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 versionaverage 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None