Tests cenobamate for frequent seizures in intensive care patients
Tests the drug cenobamate in adults with epilepsy who have frequent seizures in intensive care.
Plain-language title generated from the registry record
Registry title: Cenobamate in the Intensive Care Unit
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06352723, who can take part
Where in United States
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brigham and Women's Hospital
- Trial code
- NCT06352723
- Record updated
- 30 March 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: On medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital); History of medication-related rash; Counterindication to cenobamate as described in the prescribing information.