NCT06579573招募中3 期
ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 25
- 主要终点
- Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval
研究概览
简要总结
To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender and age: Japanese patients, regardless of gender, aged 12 years or older at the time of informed consent.
- •Subject has a clinical diagnosis of Primary Generalized Tonic-Clonic (PGTC) seizures in the setting of idiopathic generalized epilepsy.
- •Subject experiences at least 5 Primary Generalized Tonic-Clonic (PGTC) seizures in 12 weeks.
- •Subject is currently receiving 1 to a maximum of 3 concomitant Antiepileptic Drugs(AEDs) with fixed dosing regimens
排除标准
- •Subject has a history of status epilepticus that required hospitalization within 15 months prior to enrollment.
- •Subject has seizure clusters where individual seizures cannot be counted orclassified.
- •History of non-epileptic or psychogenic seizures.
- •Subject has a concomitant diagnosis of Partial Onset Seizure(POS).
- •Subject has a history of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms(DRESS), Drug-induced hypersensitivity syndrome(DIHS)) or any drug-related rash requiring hospitalization.
研究组 & 干预措施
Cenobamate
Experimental
干预措施: Cenobamate (Drug)
结局指标
主要结局
Percentage Change in generalized tonic-clonic (PGTC) seizure frequency per 28-Day Interval
时间窗: 12 Weeks of the Maintenance Phase
Convert the frequency of generalized tonic-clonic seizures (PGTC) in the Maintenance Phase and Pre-treatment Phase to a 28-day interval. Calculate the percentage change for these.
次要结局
- Percentage Change in all generalized seizure frequency per 28-Day(12 Weeks of the Maintenance Phase)
- Percentage of Subjects with Reduction in Generalized Seizure Frequency per 28-Day Interval(12 Weeks of the Maintenance Phase)
研究者
研究点 (25)
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