Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107848
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2005-04-08
Brief Title:
PROVIGIL Modafinil Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep ApneaHypopnea Syndrome
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A 1 Year Open Label Flexible Dosage Extension Study to Assess the Safety and Continued Effectiveness of PROVIGIL Modafinil Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or 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 objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness ES associated with narcolepsy or OSAHS obstructive sleep apneahypopnea when administered for up to 12 months Safety and tolerability will be evaluated throughout the study by means of adverse event information clinical laboratory test results vital signs measurements and body weight and height measurements quarterly physical examination findings and 12 lead electrocardiograph ECG evaluations at the end of the study In addition the cognitive and behavioral effects of PROVIGIL will be assessed quarterly as measured by the Child Behavior Checklist for Ages 6-18 CBCL6-18 a brief psychiatric interview and the Kaufman Brief Intelligence Test KBIT 2
Detailed Description:
PROVIGIL is a registered 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