Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00080288
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2004-03-25
Brief Title:
SafetyEfficacy Study With Armodafinil CEP-10953 in Treatment of Excessive Sleepiness Associated With Chronic SWSD
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 mg as Treatment for Adults With Excessive Sleepiness Associated With Chronic Shift Work Sleep Disorder
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 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
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