A Multicenter, Open-label Trial to Assess the Safety and Tolerability of a Single Intravenous Loading Dose of Lacosamide Followed by Oral Lacosamide Maintenance as Adjunctive Therapy in Subjects With Partial-onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
研究概览
简要总结
The purpose of the trial is to evaluate the safety of intravenous (iv) lacosamide delivered in a single dose followed by 6.5 days of oral lacosamide treatment in subjects with partial-onset seizures.
详细描述
This multicenter, open-label trial examined safety and tolerability of rapid initiation of adjunctive lacosamide via a single intravenous loading dose followed by oral maintenance treatment in subjects 16 - 60 years of age with partial-onset seizures. Three consecutive 25-subject cohorts were given a progressively increasing dose of lacosamide (200, 300, 400 mg) administered as a single 15-minute intravenous (iv) loading dose followed by the equivalent daily dose administered orally twice daily for 6.5 days with the first oral dose 12 hours after the iv dose. A fourth cohort of 25 subjects repeated the 300 mg dose to provide safety data on a total of 50 subjects at the highest well-tolerated dose.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epilepsy with simple partial seizures and/or complex partial seizures
- •Stable dose regimen of 1 to 2 marketed antiepileptic drug(s) (AED(s)) for 28 days prior to screening and duration of trial
- •Acceptable candidate for venipuncture and intravenous (iv) infusion
- •At least 1 partial seizure with motor component per 90 days
- •Maximum allowed seizure frequency during 28 days prior to screening is 40 partial seizures of any type
排除标准
- •Previous use of lacosamide
- •History of primary generalized seizures
- •History of status epilepticus within last 12 months
- •History of cluster seizures during 8 week period prior to screening
- •Non-epileptic events, including psychogenic seizures that could be confused with seizures
- •Use of neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics within 28 days prior to screening
- •Received any rescue benzodiazepines more than once during the 28 days prior to screening
- •Concomitant treatment of felbamate or previous felbamate therapy within last 6 months
- •Prior or concomitant vigabatrin use
研究组 & 干预措施
Lacosamide 200 mg cohort
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
干预措施: lacosamide (Drug)
Lacosamide 300 mg combined cohorts
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
干预措施: lacosamide (Drug)
Lacosamide 400 mg cohort
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
干预措施: lacosamide (Drug)
结局指标
主要结局
Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
时间窗: Treatment period (up to 7 days)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
时间窗: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
次要结局
- Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion(0-4 hours post start of the infusion)