Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078325
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2004-02-23
Brief Title:
Armodafinil CEP-10953 in Treatment of Excessive Sleepiness Associated With Obstructive Sleep ApneaHypopnea SyndromeOSAHS
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 Residual Excessive Sleepiness Associated With Obstructive Sleep ApneaHypopnea Syndrome
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 obstructive sleep apneahypopnea syndrome OSAHS by measuring mean sleep latency from the Maintenance of Wakefulness Test MWT 30-minute version average of 4 naps at 0900 1100 1300 and 1500 and by Clinical Global Impression of Change CGI-C ratings as related to general condition at week 12 or last post-baseline visit
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