NCT07219407招募中2 期
An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.
详细描述
This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.
- •Diagnosis of refractory focal epilepsy
- •Stable RNS(c) system settings
- •A demonstrated history of compliance with RNS(c) system data interrogation and upload
- •Good overall health other than focal epilepsy, per Investigator.
- •BMI ≥ 18 kg/m^2 and ≤ 45 kg/m^2
- •Willing and able to adhere to all aspects of the protocol.
排除标准
- •Known of hypersensitivity to RAP-219
- •Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator
- •Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
研究组 & 干预措施
RAP-219
Experimental
干预措施: RAP-219 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112
次要结局
- Change in clinical seizure-free day frequency(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Percent change in clinical seizure frequency(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Clinical seizure 25%, 50%, 75%, and 100% responder proportions(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Longest clinical seizure-free interval(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Time to pre-randomization clinical seizure count(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- RNS long episode 30%, 50%, 75% or with 100% responder proportions(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Percent change in RNS long episode frequency(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Change in RNS long episode-free day frequency(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Longest RNS long episode-free interval(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Time to pre-randomization long episode count(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Percent change in RNS estimated electrographic seizure frequency(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Clinical Global Impression of Change (CGI-C) responder count and proportions(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
- Patient Global Impression of Change [PGI-C] responder count and proportions(Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.)
研究者
研究点 (7)
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