Cenobamate in the Intensive Care Unit

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06352723
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cenobamate
    400mg load plus 100mg a day for maximum of 14 days

Primary Outcome Measure

Target level [ Time Frame: 6 hours after bolus ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

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