NCT07594158招募中3 期
A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.
Ono Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年5月30日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
详细描述
Secondary objectives:
To evaluate the efficacy of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset (focal) seizures
To evaluate the pharmacokinetics of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset 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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
- •Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
- •Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
- •Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.
排除标准
- •Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
- •Patients with a history of non-epileptic psychogenic seizures.
- •Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
- •Patients diagnosed with Lennox-Gastaut syndrome.
- •Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome [DIHS]) or drug-induced rash requiring hospitalization.
研究者
研究点 (1)
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