Cenobamate in the Intensive Care Unit (CENOBITE)

March 25, 2026 updated by: Jong Woo Lee, Brigham and Women's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cenobamate
400mg load plus 100mg a day for maximum of 14 days
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target level
Time Frame: 6 hours after bolus
Percentage of patients reaching target level of 10±2 ug/mL after load.
6 hours after bolus
Maintenance level
Time Frame: Up to 14 days
Percentage of patients maintaining daily therapeutic level of 10±2 ug/mL
Up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure cessation
Time Frame: Up to 14 days
Percentage of seizure cessation within 24 hours of reaching the target level.
Up to 14 days
Seizure burden change
Time Frame: Up to 14 days
Percentage change in seizure burden over 24 hours
Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Jong Woo Lee, MD, PhD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P000856

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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