IV Lacosamide: The Safety of Intravenous Lacosamide
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Measure post-infusion lacosamide plasma concentrations
研究概览
简要总结
The purpose of this study is to evaluate the safety of IV Lacosamide in children ages 4-35.
详细描述
The objective of this study is to evaluate the safety of IV Lacosamide in children ages 4 years to 35 years, inclusive who are unable to take oral medications or require parenteral administration of IV Lacosamide Occasionally, patients over the age of 20 are seen at LeBonheur Children's Hospital due to the complexity of their condition, or due to a long relationship with their physician. These are exceptions which are reviewed on a case by case basis and are approved by the hospital administrator for admissions and outpatient testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient or LAR must sign informed consent
- •Diagnosis of partial onset currently uncontrolled
- •Patient must have received anti-epileptic drug therapy prior to initiation
- •Patient must have a medical condition in which parental administration is desireable
- •Male or female
- •Ages 4-35
排除标准
- •Patient has participated in a study involving IV Lacosamide
- •Patient has had an episode of status epilepticus in the last 3 months
- •Drug history to lacosamide pregnant or lactating
- •If of child bearing age, must have pregnancy test
- •Patient has participated in an experimental drug study in last 30 days
- •Patients with significant active hepatic or renal disease.
- •Patients with known cardiac disease.
研究组 & 干预措施
Group A
IV Lacosamide administered (intravenously) over 30 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1 mg/ kg and 2.9 mg/kg over 30 minutes.
干预措施: IV Lacosamide (Drug)
Group B
IV Lacosamide to be administered (intravenously) over 15 minutes: 0.7mg/kg, 1.4 mg/kg, 2.1mg/kg, 2,4 mg/kg
干预措施: IV Lacosamide (Drug)
结局指标
主要结局
Measure post-infusion lacosamide plasma concentrations
时间窗: 2 years
Serum lacosamide level drawn from the arm opposite intravenous infusion
Measure changes in EKG, PR interval
时间窗: 2 years
PR interval changes measured in seconds
Number of participants with treatment-related adverse events (TEAEs), reported or observed.
时间窗: 2 years
Bradycardia, hypotension, fatigue, nausea, somnolence.
次要结局
未报告次要终点
研究者
James W. Wheless
Principal Investigaor, Neurolgy Division Chief
Le Bonheur Children's Hospital