Cenobamate in the Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cenobamate.
- Who it may be relevant to
- Registry conditions: Epilepsy, Neurologic Disorder. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus
Overview
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.
Interventions
- 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
Primary outcome measures
- Target level [Time frame: 6 hours after bolus]
- Maintenance level [Time frame: Up to 14 days]
Secondary outcome measures (2)
- Seizure cessation [Time frame: Up to 14 days]
- Seizure burden change [Time frame: Up to 14 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brigham and Women's Hospital — Boston
Publications
- 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. PMID 37064924
Identifiers
NCT: NCT06352723 · 2024P000856