IV Lacosamide: The Safety of Intravenous Lacosamide
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the safety of IV Lacosamide given as a rapid infusion.
研究概览
简要总结
To evaluate the safety of IV Lacosamide in children with partial-onset epilepsy, ages 4-35 years old, inclusive, who are either unable to take oral medication or require intravenous administration of IV Lacosamide.
详细描述
Lacosamide tablets and intravenous formulations were both approved in the United States in the fall of 2008. Lacosamide is indicated for use as adjunctive therapy in the treatment of partial onset seizure disorder in patients' age seventeen years and older. A parenteral dosage form of Lacosamide is desirable for patients who are temporarily unable to take medication orally. The objective of this study is to evaluate the safety of IV Lacosamide in children with epilepsy, ages 4 to 35 years, who are either unable to take oral medication, or whom parenteral administration of IV Lacosamide is desirable.
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
- 否
入选标准
- •Patients must have a diagnosis of epilepsy and have received anti-epileptic drug therapy prior to initiation of IV Lacosamide
- •Patients must have a medical condition in which the parenteral administration of Lacosamide is desirable.
- •Patients may be male or female.
- •Patients must be 4 years of age or older, and less than age 35 years.
- •Patient or his / her legally authorized representative must sign an informed consent form prior to any study specific procedures.
排除标准
- •Patients will be excluded from entry into the study if any of the following are true:
- •Patient has previously participated in any other intravenous Lacosamide study.
- •Patient has status epilepticus within the last 3 months.
- •Patient has a history of drug allergy to Lacosamide.
- •Patient is pregnant.
- •Patient has taken experimental drug within last 30 days.
- •Patient with significant hepatic or renal disease.
研究组 & 干预措施
Group 1A
Lacosamide, IV, 50 mg, once, 30 minutes
干预措施: Lacosamide (Drug)
Group 2A
Lacosamide, IV, 100 mg, once, 30 min
干预措施: Lacosamide (Drug)
Group 3A
Lacosamide, IV, 150 mg, once, 30 min
干预措施: Lacosamide (Drug)
Group 4A
Lacosamide, IV, 200 mg, once, 30 min
干预措施: Lacosamide (Drug)
Group 1B
Lacosamide, IV, 50 mg, once, 15 min
干预措施: Lacosamide (Drug)
Group 2B
Lacosamide, IV, 100 mg, once, 15 min
干预措施: Lacosamide (Drug)
Group 3B
Lacosamide, IV, 150 mg, once, 15 min
干预措施: Lacosamide (Drug)
Group 4B
Lacosamide, IV, 200 mg, once, 15 min
干预措施: Lacosamide (Drug)
结局指标
主要结局
To evaluate the safety of IV Lacosamide given as a rapid infusion.
时间窗: one year
The safety of IV Lacosamide will be assessed in patients in whom parental administration of Lacosamide is warranted.
次要结局
未报告次要终点
研究者
James W. Wheless
Principal Investigator
Le Bonheur Children's Hospital