Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maintenance level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cenobamate
400mg load plus 100mg a day for maximum of 14 days
干预措施: Cenobamate (Drug)
结局指标
主要结局
Maintenance level
时间窗: Up to 14 days
Percentage of patients maintaining daily therapeutic level of 10±2 ug/mL
Target level
时间窗: 6 hours after bolus
Percentage of patients reaching target level of 10±2 ug/mL after load.
次要结局
- Seizure cessation(Up to 14 days)
- Seizure burden change(Up to 14 days)
研究者
Jong Woo Lee
Principal Investigator
Brigham and Women's Hospital