Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505284
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2007-07-20
Brief Title:
An Evaluation of the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Parallel-Group Trial to Evaluate the Efficacy and Safety of E2007 in Patients With Painful Diabetic Neuropathy
Status:
COMPLETED
Status Verified Date:
2013-02
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 efficacy and safety of Perampanel in patients with painful diabetic neuropathy
Detailed Description:
This is a randomized double-blind placebo-controlled parallel-group study This is a 5-arm 21-week study comprised of up to a 2-week Screening period a 15-week Dose-Escalation and Maintenance Phase using 4 doses of E2007 2 mg 4 mg 6 mg and 8 mg or placebo and a 4-week single-blind placebo Follow-Up Phase Patients will be randomly assigned to one of the five treatment groups Those patients assigned to receive either 4 mg 6 mg or 8 mg E2007 will be escalated to the appropriate dose according to an escalation schedule All patients will take four identical-looking tablets on a daily basis for the entire study duration for blinding purposes
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 |
|---|---|---|---|
| 2006-006488-22 | EUDRACT_NUMBER | None | None |