Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107809
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-04-08
Brief Title:
Study of PROVIGIL Modafinil Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep ApneaHypopnea Syndrome
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Assess the Efficacy and Safety of PROVIGIL Modafinil Treatment 100 200 and 400 mgDay in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep ApneaHypopnea Syndrome
Status:
COMPLETED
Status Verified Date:
2014-05
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 objectives of the study are to determine the effectiveness of PROVIGIL treatment compared to placebo treatment in children and adolescents with excessive sleepiness ES associated with obstructive sleep apneahypopnea syndrome OSAHS as assessed by
mean sleep latency from the Multiple Sleep Latency Test MSLT average of 4 naps performed at 0900 1100 1300 and 1500 at the last post baseline observation week 6 or early termination
the Clinical Global Impression of Change CGI-C ratings for ES at the last post baseline observation week 6 or early termination
mean sleep latency from the Multiple Sleep Latency Test MSLT average of 4 naps performed at 0900 1100 1300 and 1500 at the last post baseline observation week 6 or early termination
the Clinical Global Impression of Change CGI-C ratings for ES at the last post baseline observation week 6 or early termination
Detailed Description:
PROVIGIL is a trademark of Genelco SA licensed to Cephalon Inc
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