Cenobamate in the Intensive Care Unit
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cenobamate
DrugStudy 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
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: CenobamateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Target level
Percentage of patients reaching target level of 10±2 ug/mL after load.
Time frame
6 hours after bolus2
Maintenance level
Percentage of patients maintaining daily therapeutic level of 10±2 ug/mL
Time frame
Up to 14 daysSecondary outcomes
1
Seizure cessation
Percentage of seizure cessation within 24 hours of reaching the target level.
Time frame
Up to 14 days2
Seizure burden change
Percentage change in seizure burden over 24 hours
Time frame
Up to 14 daysSponsors and contacts
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Source ClinicalTrials.gov
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