A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of CB03-154 in Subjects Diagnosed With Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To assess the long-term tolerability and safety of CB03-154 in patients diagnosed with epilepsy.
研究概览
简要总结
CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.
详细描述
This is an open-label extension study based on the Phase 2 clinical trial CB03-154-EP201. The study aims to assess the long-term safety, tolerability, efficacy, and pharmacokinetics (PK) of CB03-154 at a maximum dose of 20 mg administered orally once daily (QD) in patients with epilepsy. Eligible subjects are those who successfully completed the prior CB03-154-EP201 study without early discontinuation. The treatment in this extension study will last for up to two years.
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
- •1. The subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.
- •2. Subject must have successfully completed the DBP and have not terminated early from Study CB03-154-EP201, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study, and judged to be efficacious based on the blinded data review (in the opinion of the investigator).
- •3. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.
- •4. Subject is able to keep accurate seizure diaries.
排除标准
- •Subject met any of the withdrawal criteria while in Study CB03-154-EP
- •Subject has any medical condition, personal circumstance, or ongoing AE (from Study CB03-154-EP201) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.
- •3. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy during the study and until 28 days after completion of this study.
研究组 & 干预措施
The Subjects from CB03-154-EP201
The subjects who completed the CB03-154-EP201 will be enrolled and begin with a two-week course of CB03-154 at 10 mg QD. Upon demonstrating good tolerability, the dose will be increased to 20 mg QD and continued for up to two years.
干预措施: CB03-154 (Drug)
结局指标
主要结局
To assess the long-term tolerability and safety of CB03-154 in patients diagnosed with epilepsy.
时间窗: In the entire period of the whole study, including a treatment period up to 2 years (104 weeks) and a post treatment follow-up period of 8 weeks.
Severity and frequency of associated AEs/serious adverse events (SAEs)
To assess the long-term efficacy of CB03-154 in patients diagnosed with epilepsy.
时间窗: In the entire period of the whole study, including a treatment period up to 2 years (104 weeks) and a post treatment follow-up period of 8 weeks.
Median percent change (MPC) in monthly (28 days) seizure frequency from baseline (the end of the DBP of study CB03 154-EP201) to the entire treatment period.
次要结局
- Maximum Plasma Concentration (Cmax).(In the Week 2±3 days , Week 4±3 days , Week 13±3 days , and Week 26±7 days.)