Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352723
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-03
Brief Title:
Cenobamate in the Intensive Care Unit
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
CENOBITE
Brief Summary:
The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium CCEMRC A total of 10 patients will be recruited over a period of one year with each patient undergoing monitored treatment regimen Each site will obtain its own approval from their institutional review board Data will be shared through the MGB REDCap raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH
Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms DRESS syndrome a potential adverse reaction will be a key aspect of the study Regular assessments including RegiSCAR scoring a validated scoring system for DREeSS5 daily serum cenobamate level measurements and comprehensive lab tests will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome
Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms DRESS syndrome a potential adverse reaction will be a key aspect of the study Regular assessments including RegiSCAR scoring a validated scoring system for DREeSS5 daily serum cenobamate level measurements and comprehensive lab tests will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None