Cenobamate in the Intensive Care Unit

Starting soon · Early Phase 1

Conditions studied: Epilepsy, Neurologic Disorder

In brief

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.

Key facts

Study ID

NCT06352723

Run by

Brigham and Women's Hospital

People needed

10

Starts

2026-06-01

Expected to finish

2029-06-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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