Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368472
Status:
COMPLETED
Last Update Posted:
2015-12-10
First Post:
2006-08-22
Brief Title:
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
An Open-Label Extension Phase of the Double-Blind Placebo-Controlled Dose-Escalation Parallel-Group Study of E2007 Perampanel as an Adjunctive Therapy in Patients With Refractory Partial Seizures
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety of perampanel given as adjunctive long-term treatment in patients with refractory partial onset seizures
Detailed Description:
This is an Open-Label Extension OLE study for patients who completed the E2007-A001-206 NCT00144690 or the E2007-G000-208 NCT00416195 double-blind placebo-controlled dose-escalation parallel-group studies
This study consisted of 3 periods OLE Titration 12 weeks OLE Maintenance 424 weeks and OLE Follow-up 4 weeks During the OLE Titration Period participants were titrated to their maximum tolerated dose MTD of perampanel up to a maximum of 12 mgday The OLE Maintenance Period began at completion of the OLE Titration Period participants remained on the dose achieved at the end of the OLE Titration Period unless dose adjustment for tolerability reasons was necessary Participants who either withdrew from the study prematurely or completed the OLE Maintenance Period returned for a final visit at the end of the 4-week OLE Follow-up Period
This study consisted of 3 periods OLE Titration 12 weeks OLE Maintenance 424 weeks and OLE Follow-up 4 weeks During the OLE Titration Period participants were titrated to their maximum tolerated dose MTD of perampanel up to a maximum of 12 mgday The OLE Maintenance Period began at completion of the OLE Titration Period participants remained on the dose achieved at the end of the OLE Titration Period unless dose adjustment for tolerability reasons was necessary Participants who either withdrew from the study prematurely or completed the OLE Maintenance Period returned for a final visit at the end of the 4-week OLE Follow-up Period
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