A Multicenter, Open-Label Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of Lacosamide (LCM) Oral Solution (Syrup) As Adjunctive Therapy In Children With Partial-Onset Seizures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 47
- 试验地点
- 21
- 主要终点
- Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
研究概览
简要总结
The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).
详细描述
Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.
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
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female between 1 month and 17 years of age inclusive
- •Subject's Body Mass Index (BMI) is within the 5th to 95th percentile for his/her age group
- •Subject has a diagnosis of epilepsy with partial-onset seizures
- •Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment with at least 2 anti-epileptic drugs (AEDs) (concurrently or sequentially)
- •Subject has been observed to have at least 2 countable seizures in the 4-week period prior to Screening
- •Subject is on a stable dosage regimen of 1 to 3 AEDs
排除标准
- •Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device
- •Subject with seizures that are uncountable due to clustering during the 8-week period prior to study entry
- •Subject is on a ketogenic or other specialized diet
- •Subject has a history of primary generalized epilepsy
- •Subject has a history of status epilepticus within the 6-month period prior to Screening
- •Subject is receiving concomitant treatment with felbamate or has received previous felbamate therapy within the last 6 months prior to Screening
- •Subject has taken or is currently taking vigabatrin
- •Subject is taking monoamine oxidase (MAO) inhibitors or narcotic analgesics
- •Subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months
研究组 & 干预措施
Lacosamide - Age 5 - 11 years
Cohort 1 (Age 5 - 11 years); up to 8 mg/kg/day
干预措施: Lacosamide (Drug)
Lacosamide - (Age 12 - 17 years)
Cohort 2 (Age 12 - 17 years); 12 mg/kg/day.
干预措施: Lacosamide (Drug)
Lacosamide (Age 2 - 4 years)
Cohort 3 (Age 2 - 4 years); 12 mg/kg/day.
干预措施: Lacosamide (Drug)
Lacosamide (Age 5 - 11 years)
Cohort 4 (Age 5 - 11 years); 12 mg/kg/day.
干预措施: Lacosamide (Drug)
Lacosamide (Age 1 month - < 2 years)
Cohort 5 (Age 1 month to < 2 years); 12 mg/kg/day
干预措施: Lacosamide (Drug)
结局指标
主要结局
Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)
时间窗: 13 weeks
次要结局
- Change in Seizure Frequency From Baseline to End of Treatment(From Baseline to End of Treatment (approximately 13 weeks))
- Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination(Visit 5 (Day 27/28) or Early Termination)
- Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination(Visit 5 (Day 27/28) or Early Termination)
- Plasma Ctrough Values for Lacosamide at Day 7(Day 7)
- Plasma Ctrough Values for SPM 12809 at Day 42(Day 42)
- Plasma Ctrough Values for Lacosamide at Day 28(Day 28)
- Plasma Ctrough Values for Lacosamide at Day 35(Day 35)
- Plasma Ctrough Values for Lacosamide at Day 42(Day 42)
- Plasma Ctrough Values for SPM 12809 at Day 7(Day 7)
- Plasma Ctrough Values for SPM 12809 at Day 28(Day 28)
- Plasma Ctrough Values for SPM 12809 at Day 35(Day 35)