Cenobamate in the Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy Neurologic Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cenobamate

400mg load plus 100mg a day for maximum of 14 days

Group Type EXPERIMENTAL

Cenobamate

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes