An Open-label, Multicenter Study to Evaluate the Safety of Adjunctive Treatment With Intravenous Levetiracetam (L059 IV) in Epilepsy Patients Aged ≥ 16 Years With Partial Onset Seizures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
研究概览
简要总结
To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or female aged ≥ 16 years
- •Subject has Partial Onset Seizures that are classifiable according to the 1981 International League Against Epilepsy (ILAE) classification of Epileptic Seizures
- •Subject weighs ≥ 40 kg
- •Subject is currently taking Levetiracetam (LEV) as an adjunctive antiepileptic oral treatment with 1 to 3 other Antiepileptic Drugs (AEDs)
排除标准
- •Subject has problems with venous accessibility
- •Subject has participated in another clinical/pharmacological study during the last 4 weeks prior to the Screening Visit
- •Subject is pregnant or lactating
- •Subject has a history of suicide attempt(s) or presents with current depressive signs, current suicidal ideation, and/or behavior
- •Subject has clinically significant Electrocardiogram (ECG) abnormalities according to the investigator
研究组 & 干预措施
Levetiracetam
Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days)
时间窗: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)
An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days)
时间窗: During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18)
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention.
次要结局
- Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1(Day 1)
- Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4(Day 4)
- Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1(Day 1)
- Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4(Day 4)
- Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period(During the Evaluation Period (Day 1 to Day 4))