Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078312
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2004-02-23
Brief Title:
Armodafinil CEP-10953 for Treatment of Narcolepsy Obstructive Sleep ApneaHypopnea Syndrome or Chronic Shift Work Sleep Disorder
Sponsor:
Cephalon
Organization:
Teva Branded Pharmaceutical Products RD Inc
Study Overview
Official Title:
A 12-Month Open-Label Flexible-Dosage 100 to 250 mgDay Study of the Safety and Efficacy of CEP-10953 in the Treatment of Patients With Excessive Sleepiness Associated With Narcolepsy Obstructive Sleep ApneaHypopnea Syndrome or Chronic Shift Work Sleep Disorder With an Open-Ended Extension Period
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 evaluate the safety and tolerability of Armodafinil CEP-10953 administered on a flexible-dosage regimen of 100 to 250 mgday for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy obstructive sleep apneahypopnea syndrome OSAHSregular users of nasal continuous positive airway pressure nCPAP therapy or chronic shift work sleep disorder SWSD
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