Cenobamate in the Intensive Care Unit
- Registration Number
- NCT06352723
- Lead Sponsor
- Brigham and Women's Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cenobamate Cenobamate 400mg load plus 100mg a day for maximum of 14 days
- Primary Outcome Measures
Name Time Method Target level 6 hours after bolus Percentage of patients reaching target level of 10±2 ug/mL after load.
Maintenance level Up to 14 days Percentage of patients maintaining daily therapeutic level of 10±2 ug/mL
- Secondary Outcome Measures
Name Time Method Seizure cessation Up to 14 days Percentage of seizure cessation within 24 hours of reaching the target level.
Seizure burden change Up to 14 days Percentage change in seizure burden over 24 hours
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States