Cenobamate for Epilepsy
(CENOBITE Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJong Woo Lee, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with nervous system disorders, epilepsy, or other neurological conditions who require intensive care. Participants will be closely monitored in a multi-center study involving leading critical care EEG monitoring sites.

Inclusion Criteria

Undergoing EEG monitoring

I am between 18 and 70 years old.

I experience more than one seizure per hour or have had a long seizure lasting more than 5 minutes.

+1 more

Exclusion Criteria

History of medication-related rash

I am taking medication that affects how my body absorbs food or drugs.

I cannot take cenobamate due to health reasons.

Participant Groups

The CENOBITE study tests the drug Cenobamate on a small group of 10 patients to see how it affects those with severe neurological issues. Patients' reactions are tracked using advanced tools like EEG and regular lab tests.

1Treatment groups

Experimental Treatment

Group I: CenobamateExperimental Treatment1 Intervention

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

Cenobamate is already approved in United States, European Union, United Kingdom, Canada for the following indications:

🇺🇸 Approved in United States as Xcopri for:

Partial-onset seizures in adults

🇪🇺 Approved in European Union as Ontozry for:

Adjunctive treatment of focal-onset seizures with or without secondary generalization in adults with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medications

🇬🇧 Approved in United Kingdom as Ontozry for:

Add-on treatment for focal-onset seizures with or without secondary generalization in adults with epilepsy who have not been adequately controlled despite a history of treatment with at least one other add-on treatment

🇨🇦 Approved in Canada as Ontozry for:

Adjunctive treatment of focal-onset seizures with or without secondary generalization in adults with epilepsy who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medications