EUCTR2020-003447-28-IT进行中（未招募）1 期
An Open-Label Extension Study of XEN496 in Pediatric Subjects withKCNQ2 Developmental and Epileptic Encephalopathy - EPIK OLE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject completed participation in the primary study, XPF-009-301. A
- •subject who withdraws from the primary study due to meeting protocolspecified worsening criteria will be considered as having completed participation in the primary study.
- •2. The caregiver is willing and able to be compliant with diary completion, visit schedule, and study drug administration.
- •3. Subject's caregiver achieved a minimum of 85% compliance with daily
- •diary completion during both baseline and the double-blind period of the
- •primary study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any AE or SAE during Study XPF-009-301, which in the opinion of the
- •investigator and sponsor's medical monitor, would preclude the subject's
- •entry into the OLE.
- •2. A clinically significant condition or illness, or symptoms other than
- •those resulting from KCNQ2-DEE, present at screening/baseline that, in
- •the opinion of the investigator, would pose a risk to the subject if s/he
- •were to enter the study.
- •3. Any conditions that were specified as exclusion criteria in the primary
- •study (XPF 009-301).
- •4. It is anticipated that the subject will require treatment with at least 1
- •of the disallowed medications during the study.
- •5. Any change in cardiac rhythm or atrioventricular conduction in the
- •primary study that, in the investigator's opinion, is a significant risk to
- •subject safety.
研究者
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