NCT06352723Not yet recruitingEarly phase 1
Cenobamate in the Intensive Care Unit
Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 3 Apr 2024
- Start date
- Jun 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Epilepsy
- NCT number
- NCT06352723
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From Jun 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On medication or device affecting enteral absorption (e.g., phenobarbital, pentobarbital).
Other illness
- History of medication-related rash.
Other
- Counterindication to cenobamate as described in the prescribing information.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.