Epilepsy, Neurologic Disorder
Conditions
Keywords
ICU
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.
Interventions
DRUGCenobamate
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
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTJong Woo Lee, MD, PhD
CONTACTMelanie Choe, BA
PRINCIPAL_INVESTIGATORJong Woo Lee, MD, PhD
Brigham and Women's Hospital
Outcome results
None listed