Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 90
- 主要终点
- Change From Baseline in Seizure Frequency
研究概览
简要总结
The purpose of this study is to examine the efficacy and safety of Eslicarbazepine acetate (BIA 2-093) when given with other anti-epileptic drugs to treat children with partial seizures whose condition has not been controlled by other drug treatments.
详细描述
Partial epilepsy, the commonest form of epilepsy, is a difficult condition to treat with many patients continuing to have symptoms despite trying several medications. Lack of efficacy and adverse effects are commonly associated with current anti-epileptic drugs.
This study will examine the efficacy in addition to safety and tolerability of a new anti-epileptic drug, Eslicarbazepine acetate (BIA 2-093), as an adjunctive therapy for refractory partial seizures in children.
The primary analysis variables are:
- The responder rate (the proportion of patients with at least a 50% reduction in standardised seizure frequency)
- The relative reduction in standardised seizure frequency
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •girls of child-bearing potential have to follow reliable and medically acceptable contraceptive method throughout the study
- •diagnosis of epilepsy for at least 6 months prior to enrolment
- •at least 4 partial-onset seizures in the last month prior to enrolment despite stable therapy with adequate dosage of 1 or 2 AEDs
- •at least 4 partial-onset seizures during each 4-week interval of the 8-week baseline period
- •previous treatment with three or more AEDs, in their maximum tolerated doses, for at least one month, without seizure control
- •current treatment with 1 or 2 AEDs (any except oxcarbazepine); if present, vagus nerve stimulation is considered an AED
- •stable dose regimen of AEDs during the 8-week baseline period
- •cooperation and willingness to complete all aspects of the study, including hospitalisation if required
- •written informed consent to participate in the study in accordance with local legislation
排除标准
- •primarily generalised seizures
- •baseline seizure frequency substantially different from usual seizure frequency
- •known progressive neurological disorders
- •history of status epilepticus within the 3 months prior to enrolment
- •seizures of non-epileptic origin
- •Lennon-Gastaut
- •West syndrome
- •Major psychiatric disorders
- •Previous treatment any study with Eslicarbazepine acetate
研究组 & 干预措施
Eslicarbazepine acetate
To receive Eslicarbazepine acetate in addition to concomitant therapy
干预措施: Eslicarbazepine acetate (BIA 2-093) (Drug)
Placebo
To receive placebo in addition to concomitant therapy
干预措施: Eslicarbazepine acetate (Drug)
结局指标
主要结局
Change From Baseline in Seizure Frequency
时间窗: Baseline up to Visit 7
Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Responder Rate
时间窗: baseline up to Visit 7
Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
次要结局
未报告次要终点