Seizure Therapy With Intravenous Levetiracetam and Lorazepam
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Seizures
研究概览
简要总结
The overarching aim of STILL is assessment of IV LEV in the management of seizures in the ED setting. The main study endpoints are considered in the two patient groups of interest (SE and non-SE):
- For non-SE patients, STILL will compare IV LEV vs. the current standard-care of placebo, with respect to the following questions:
- Does IV LEV administration result in lower seizure duration and/or recurrence rate than does administration of placebo? (Ho: No difference in seizure duration or recurrence rates between the two groups.)
- Is IV LEV associated with a different rate of significant side effects than placebo? (Ho: No difference in significant side effect rates between the two groups.)
- For SE patients, STILL will compare [IV LEV + lorazepam 2mg] vs. [lorazepam 3 mg], with respect to the following questions:
- Does addition of IV LEV to a BZD allow for a BZD-sparing effect (i.e. achievement of seizure control with lower dose of BZD)? (Ho: No difference in seizure duration and/or recurrence rates between the two groups.)
- Is IV LEV + lower-dose BZD associated with a different rate of significant side effects than the higher-dose BZD administered as monotherapy? (Ho: No difference in significant side effect rates between the two groups.)
详细描述
The study will enroll adults (age at least 18 years) in the EDs of MGH or BWH. Patients will be classified, depending upon their clinical presentation, into the SE group or the non-SE group. The total enrollment projected for non-SE patients is 150; the total enrollment projected for SE patients is 200. It is expected that at least 3 years may be required to enroll the requisite number of patients.
Patients are eligible for study enrollment if they have had a seizure, and if they do not have known pregnancy or renal failure, and if they are not known to be breastfeeding. Hypotension is the only other exclusion criteria for the study. There are no other contraindications to study enrollment.
Patients evaluated at the MGH/BWH EDs for seizures may arrive by private vehicle or ambulance. A "STILL" pager will be activated by ED physicians upon notification of impending ambulance arrival with a suspected seizure patient (SE or non-SE); the pager can also be activated after patient arrival at the ED by ambulance or private vehicle.
Upon patient arrival to the ED, standard stabilization will be provided. If the patient is determined to have had a seizure, or if the patient is currently seizing, an IV will be placed (if not already present) in line with standard ED care. For the patient to be eligible for STILL, the seizure must have occurred within an hour of ED arrival.
Care providers will make a determination as to whether patients are eligible, using a checklist readily available in the ED. For patients who are determined to be eligible, the care providers will indicate whether patients are in the "SE" or "non-SE" arm - the study groups are hereafter denoted SE and non-SE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •pregnancy
- •renal failure
- •hepatic impairment
研究组 & 干预措施
1
Levetiracetam 1 g IV + Lorazepam 2 mg IV
干预措施: Levetiracetam 1 g IV + Lorazepam 2 mg IV (Drug)
2
Placebo + Lorazepam 3 mg IV
干预措施: Placebo + Lorazepam 3 mg IV (Drug)
结局指标
主要结局
Seizures
时间窗: hours
Mental status
时间窗: hours
Respiratory depression
时间窗: hours
seizure recurrence
时间窗: hours
次要结局
未报告次要终点
研究者
Joshua N. Goldstein, MD, PhD
Assistant Professor
Massachusetts General Hospital
