Ignite Creation Date:
2024-05-06 @ 6:04 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05533814
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2022-09-06
Brief Title:
A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
Sponsor:
Eisai Korea Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Multicenter Open-Label Prospective Study With an Extension Phase to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Subjects With Focal Onset Seizures With or Without Focal to Bilateral Tonic-Clonic Seizures
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
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 purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period 24 weeks of the Treatment Phase in untreated participants with focal onset seizures FOS with or without focal to bilateral tonic-clonic seizures FBTCS
Detailed Description:
The study will consist of a Core Study 36 weeks and an Extension Phase 24 weeks Core Study will consist of 4 weeks Pre-treatment Phase or Baseline and 32 weeks Treatment Phase 8 weeks Titration period and 24 weeks Maintenance period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None