Lacosamide IV and EEG/EKG (LIVE) Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Change in the number of interictal spikes
研究概览
简要总结
The purpose of this study is to evaluate the effect of different intravenous doses (IV) of a new anti-epileptic drug (AED) called lacosamide on continuous EEG (electroencephalogram) rhythms (or brain rhythms) in subjects with focal seizures and the tolerability of those doses by patients. In addition, this study will assess the effect of IV lacosamide on EKG (electrocardiogram), a test which checks for problems with the electrical activity of the heart.
详细描述
The impact of antiepileptic drugs on the EEG can vary from marked to none. A small number of AEDs also affect the EKG. Lacosamide is a new AED that selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. Information is lacking about the effect of lacosamide on brain and heart rhythms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
- •Adult patients 18-65 years
- •Diagnosis of focal epilepsy
- •Continuous EEG and video monitoring
- •Continuous EKG
- •Active EEG showing frequent spikes, electrographic or clinical seizures
排除标准
- •Subject has no IV access.
- •Subject is hemodynamically unstable.
- •Previous use of Lacosamide
- •Primary generalized epilepsy
- •Non-epileptic seizures
- •No significant cardiac, renal or hepatic disease
- •No cardiac arrhythmias including heart block
- •Subject is a pregnant or lactating woman.
研究组 & 干预措施
100 mg IV
100 mg IV lacosamide infused over 30 minutes
干预措施: Lacosamide (Drug)
200 mg IV
200 mg IV lacosamide infused over 30 minutes
干预措施: Lacosamide (Drug)
400 mg IV
400 mg IV lacosamide infused over 30 minutes
干预措施: Lacosamide (Drug)
结局指标
主要结局
Change in the number of interictal spikes
时间窗: One hour before and after drug
次要结局
- Change in frequency and quantity of background EEG rhythms(One hour before and after drug)
- Change in EKG (QT, PR interval and heart rhythm)(One hour before and after drug)
研究者
Rick McLachlan
Principal Investigator
Lawson Health Research Institute