A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400 mg/Day Monotherapy in Subjects With Partial-onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 426
- 试验地点
- 158
- 主要终点
- Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)
研究概览
简要总结
The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to Lacosamide monotherapy in subjects with Partial-onset Seizures who are withdrawn from 1 to 2 marketed antiepileptic drugs.
详细描述
Sudden unexplained death in epilepsy have been reported in epilepsy patients. A causal relationship with the administration of antiepileptic drugs has not been established. The most important known risk factor for sudden unexplained death in epilepsy (SUDEP) is the occurrence and frequency of generalized tonic-clonic seizures (GTCS). Twenty-seven patients with only GTCS were enrolled in the conversion to monotherapy study. In this study, two patients with only GTCS had SUDEP. Due to the potential increased risk of SUDEP in patients with only GTCS in a trial setting, the 1 remaining patient with only GTCS was withdrawn from this study.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of Epilepsy with Simple Partial Seizures (motor component) and or Complex Partial Seizures (with or without secondary generalization)
- •Must be experiencing 2 to 40 seizures per 28-day period
- •Stable dose of 1 or 2 marketed antiepileptic drugs
- •Second Antiepileptic Drug (AED) must be less than or equal to 50 % of the minimum recommended maintenance dose per USA product label at screening
排除标准
- •Subject has a history of primary generalized or unclassified seizures
- •Seizure disorder primarily characterized by isolated auras
- •History of status epilepticus
- •Seizures that are uncountable due to clustering
- •Has greater than 5 seizures/day
- •Subjects taking Benzodiazepines, Phenobarbital or Primidone
- •Subject has Vagus Nerve Stimulation (VNS)
- •Significant medical or psychiatric condition
- •History of alcohol or drug abuse
- •History of Ethosuximide use, Felbamate use after 1994 or Vigabatrin use after 1997
研究组 & 干预措施
Lacosamide 400 mg/day
Lacosamide 400 mg/day
干预措施: Lacosamide (Drug)
Lacosamide 300 mg/day
Lacosamide 300 mg/day
干预措施: Lacosamide (Drug)
结局指标
主要结局
Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)
时间窗: 16 Weeks Maintenance Period (approximately 112 days)
Pre-defined exit criteria: 1. A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase 2. A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase. Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion 3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization 4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation 5. Status epilepticus, or new onset of serial/cluster seizures
次要结局
- Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period(16 Weeks Maintenance Period (approximately 112 days))
- Time to First Occurrence of Any Exit Event During The Maintenance Period(16 Weeks Maintenance Period (approximately 112 days))
- Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)(Visit 9 - Visit 12 (approximately 10 weeks))
- Clinical Global Impression of Change (CGIC) From Baseline To Last Visit(Baseline; Last Visit (approximately 27 weeks))
- Patient's Global Impression of Change (PGIC) From Baseline To Last Visit(Baseline; Last Visit (approximately 27 weeks))