Cenobamate in the Intensive Care Unit

Epilepsy Clinical Trial

— CENOBITE  

Official title:

Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06352723
• Other study ID #: 2024P000856
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: April 2024
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Jong Woo Lee, MD, PhD
• Phone: 617-732-7547
• Email: jlee38[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70.
• Undergoing EEG monitoring.
• Acute frequent seizures (>1/hour) or status epilepticus (>5 min of consecutive seizures, or seizure burden >20% within past 1 hour).
• Adjunctive conventional antiseizure medication indicated.

Exclusion Criteria:

• History of medication-related rash.
• On medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital).
• Counterindication to cenobamate as described in the prescribing information.

Related Conditions & MeSH terms

• Epilepsy
• Nervous System Diseases
• Neurologic Disorder

Intervention

Drug:
• Cenobamate
Study Drug: Cenobamate 400mg x 1 NGT/G-tube (Day 1), 100mg (Day 2-14) Discontinued cenobamate upon cessation of seizures or RegiSCAR score 4-5 or at 14 days. Adjust cenobamate dose based on patient response; this may include discontinuation if seizures resolve, or increase in dose to 150mg or 200mg a day after Day 7

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carlson JM, Molyneaux BJ, Lee JW. Safe Use of Cenobamate in Super Refractory Status Epilepticus: A Case Series. Neurohospitalist. 2023 Apr;13(2):169-172. doi: 10.1177/19418744221147083. Epub 2023 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target level	Percentage of patients reaching target level of 10±2 ug/mL after load.	6 hours after bolus
Primary	Maintenance level	Percentage of patients maintaining daily therapeutic level of 10±2 ug/mL	Up to 14 days
Secondary	Seizure cessation	Percentage of seizure cessation within 24 hours of reaching the target level.	Up to 14 days
Secondary	Seizure burden change	Percentage change in seizure burden over 24 hours	Up to 14 days