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NCT Number: NCT06352723

Cenobamate in the Intensive Care Unit

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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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cenobamate

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

Primary outcomes

  1. Target level

    Time frame: 6 hours after bolus

    Percentage of patients reaching target level of 10±2 ug/mL after load.

  2. Maintenance level

    Time frame: Up to 14 days

    Percentage of patients maintaining daily therapeutic level of 10±2 ug/mL

Secondary outcomes

  1. Seizure cessation

    Time frame: Up to 14 days

    Percentage of seizure cessation within 24 hours of reaching the target level.

  2. Seizure burden change

    Time frame: Up to 14 days

    Percentage change in seizure burden over 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Jong Woo Lee, MD, PhD

CONTACT

[email protected]

617-732-7547

Melanie Choe, BA

CONTACT

[email protected]

617-525-3014

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus

Acronym: CENOBITE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 8, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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