Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416195
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2006-12-26
Brief Title:
Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Explore the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
Status:
COMPLETED
Status Verified Date:
2013-08
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:
This is a randomized double-blind placebo-controlled parallel group study to determine the maximum tolerated dose of E2007 Epilepsy patients with refractory partial seizures will be divided into two groups of 24 patients each One group will be patients who take concomitant inducing AEDs anti-epileptic drugs and the second group will be patients who do not take concomitant inducing AEDs In each group 18 patients will receive E2007 dose escalating to a maximum of 12 mg per day and six will receive placebo
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 |
|---|---|---|---|
| 2006-003702-26 | EUDRACT_NUMBER | None | None |