An Open-Label Pilot Study to Assess the Safety of Oral Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 主要终点
- Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
研究概览
简要总结
The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.
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 65 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 uncontrolled epilepsy with primary generalized tonic-clonic (PGTC) seizures and idiopathic generalized epilepsy. Diagnosis should have been established by an electroencephalogram (EEG) with generalized spike-wave discharges within 5 years of the screening visit
- •Subject has ≥1 PGTC seizure within the 12 weeks prior to the screening visit
- •Subject has a stable dose regimen of 1 to 3 marketed antiepileptic drug(s) (AEDs) with or without additional concurrent stable Vagus Nerve Stimulation (VNS). The VNS must have been in place for at least 6 months prior to study entry with constant settings for at least 28 days prior to the screening visit and during the Baseline Phase. Benzodiazepines will be counted as an AED
排除标准
- •Subject has a history of partial-onset seizures or EEG findings consistent with partial onset seizures
- •Subject has a history of status epilepticus within the 5-year Period prior to Visit 1
- •Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events
- •Subject has any medical or psychiatric condition
- •Subject has any history of alcohol or drug abuse
- •Subject is currently taking felbamate
- •Subject has ever taken vigabatrin and has no visual fields examination report available or if results of the examination are abnormal
- •Subject is on a ketogenic diet
- •Subject has a known sodium channelopathy
研究组 & 干预措施
Lacosamide
干预措施: Lacosamide (Drug)
结局指标
主要结局
Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
时间窗: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type * Seizure frequency A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures.
Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase
时间窗: From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded: * Seizure type * Seizure frequency A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures.
次要结局
- Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)(From Visit 2 (Week 4) to Visit 6 (Week 8))
- Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)(From Visit 2 (Week 4) to Visit 6 (Week 8))
- Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period(From Visit 2 (Week 4) to Visit 7 (Week 13))
- Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period(From Visit 2 (Week 4) to Visit 7 (Week 13))