Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144690
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2005-09-01
Brief Title:
E2007 Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Dose-Escalation Parallel-Group Study of E2007 Given as 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 primary objective of this study is to determine the maximal tolerated dose MTD of E2007 given twice daily bid or once a day qd in patients with refractory partial-onset seizures including secondarily generalized seizures The secondary objectives are to evaluate the safety efficacy concentration-efficacy relationship and pharmacokinetics of E2007 and the effects of E2007 on the Profile of Mood States POMS test
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-004199-18 | EUDRACT_NUMBER | None | None |