Cenobamate in the Intensive Care Unit

NCT06352723 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 2024P000856
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Neurologic Disorder

Keywords

ICU

Outcome Measures

Primary Outcomes (2)

• Target level

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

  6 hours after bolus

• Maintenance level

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

  Up to 14 days

Secondary Outcomes (2)

• Seizure cessation

  Up to 14 days

• Seizure burden change

  Up to 14 days

Study Arms (1)

Cenobamate

EXPERIMENTAL

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

Drug: Cenobamate

Interventions

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

Cenobamate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Carlson JM, Molyneaux BJ, Lee JW. Safe Use of Cenobamate in Super Refractory Status Epilepticus: A Case Series. Neurohospitalist. 2023 Apr;13(2):169-172. doi: 10.1177/19418744221147083. Epub 2023 Feb 15.

  PMID: 37064924 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Nervous System Diseases

Interventions

Cenobamate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases

Study Officials

• Jong Woo Lee, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Woo Lee, MD, PhD

CONTACT

617-732-7547; jlee38@bwh.harvard.edu

Melanie Choe, BA

CONTACT

617-525-3014; mlchoe@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single arm pilot study

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 8, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)