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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cenobamate | Experimental | 400mg load plus 100mg a day for maximum of 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenobamate | Drug | Study Drug: Cenobamate 400mg x 1 NGT/G-tube (Day 1), 100mg (Day 2-14)
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure cessation | Percentage of seizure cessation within 24 hours of reaching the target level. | Up to 14 days |
| Seizure burden change | Percentage change in seizure burden over 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Woo Lee, MD, PhD | Contact | 617-732-7547 | jlee38@bwh.harvard.edu | |
| Melanie Choe, BA | Contact | 617-525-3014 | mlchoe@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jong Woo Lee, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37064924 | Background | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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Single arm pilot study
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| Up to 14 days |