Phase 1, Open-Label Study of Carisbamate in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Concomitant medication
研究概览
简要总结
Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).
详细描述
Subjects who successfully completed the YKP509C001 study and could benefit from continued exposure to carisbamate.
This is an open-label (OL), multi-center study of carisbamate in subjects with LGS, with safety assessments from Baseline (Visit 1) through the early termination (ET)/end of study (EOS) visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed the YKP509C001 study
- •Investigator believes subject could benefit from continued exposure to study drug
- •Subjects must continue to meet all of the inclusion criteria from the YKP509C001 study
排除标准
- •Subjects must continue to not meet any of the exclusion criteria from the YKP509C001 study
- •There are no additional exclusion criteria in this study
研究组 & 干预措施
Cohort I
Subjects ≥ 18 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
干预措施: Carisbamate (Drug)
Cohort II
Subjects 12 to <18 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
干预措施: Carisbamate (Drug)
Cohort III
Subjects 6 to <12 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
干预措施: Carisbamate (Drug)
Cohort IV
Subjects 2 to <6 years of age
These subjects will reach maximum stable dose and continue onto YKP509C002.
干预措施: Carisbamate (Drug)
结局指标
主要结局
Concomitant medication
时间窗: Up to 20 months
Safety
12-lead electrocardiograms (ECGs)
时间窗: Up to 20 months
Safety
Physical examinations
时间窗: Up to 20 months
Safety
Seizure Frequency
时间窗: Up to 20 months
An assessment of seizure frequency will be made using a subject/caregiver seizure diary with seizure type and number of daily seizures recorded since the prior visit.
次要结局
- Safety- adverse events(The duration of this OL study will be until carisbamate bas been approved for treatment of LGS and is available by prescription, or development of carisbamate for LGS has stopped, whichever is first. This could occur up to 36 months.)