Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 51
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) during the study
研究概览
简要总结
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
详细描述
EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 [NCG03325439] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 [NCT01364597]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for long-term follow-up (LTFU) study participants only
- •Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439]
- •Inclusion criteria for directly enrolled (DE) study participants in Japan only
- •Study participant is ≥ 4 years to < 16 years of age
- •Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
- •Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
- •Study participant had at least 1 POS during the 4-week Screening Period
排除标准
- •Exclusion criteria for all study participants
- •Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
- •Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).
- •Exclusion criteria for long-term follow-up (LTFU) study participants only
- •- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Exclusion criteria for directly enrolled (DE) study participants in Japan only
- •Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
- •Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
- •Study participant has any clinically significant illness
- •Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
- •Study participant has a clinically significant ECG abnormality
- •Study participant had major surgery within 6 months prior to the ScrV
研究组 & 干预措施
Brivaracetam
LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.
干预措施: Brivaracetam (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) during the study
时间窗: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
Incidence of treatment-emergent serious adverse events (SAEs) during the study
时间窗: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study
时间窗: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
次要结局
未报告次要终点