A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy (X-TOLE4)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 446
- 试验地点
- 74
- 主要终点
- Severity and frequency of TEAEs, SAEs, AESIs, AEDCs, AEs leading to dose reduction, and ECIs; potentially clinically significant changes in vital signs, clinical laboratory findings, and/or 12-lead ECG; changes in ophthalmologic exams; increase in suicide risk as assessed by the C-SSRS; clinically significant changes in urological symptoms (including retention) as measured by the AUA-SI; and growth and development in adolescents assessed via physical exam and endocrine laboratory assessments.
研究概览
简要总结
To assess the safety and tolerability of long-term therapy with XEN1101 in subjects with FOS or PGTCS who have completed Study XPF-010-301, XPF-010-302, or XPF-010-303.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subject must have successfully completed the Double bling period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, 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.
- •Subject is able to keep accurate seizure diaries.
- •Subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.
- •Subject must be willing to comply with the contraception requirements as defined in protocol Section 5.
- •Male subjects must agree not to donate sperm until 3 months after the last dose of study drug. Female subjects must agree not to donate ova until 6 months after the last dose of study drug.
- •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.
排除标准
- •Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT
- •Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.
- •Female subject who is pregnant, breastfeeding, or planning to become pregnant prior to 6 months after the last dose of study drug.
- •Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.
结局指标
主要结局
Severity and frequency of TEAEs, SAEs, AESIs, AEDCs, AEs leading to dose reduction, and ECIs; potentially clinically significant changes in vital signs, clinical laboratory findings, and/or 12-lead ECG; changes in ophthalmologic exams; increase in suicide risk as assessed by the C-SSRS; clinically significant changes in urological symptoms (including retention) as measured by the AUA-SI; and growth and development in adolescents assessed via physical exam and endocrine laboratory assessments.
Severity and frequency of TEAEs, SAEs, AESIs, AEDCs, AEs leading to dose reduction, and ECIs; potentially clinically significant changes in vital signs, clinical laboratory findings, and/or 12-lead ECG; changes in ophthalmologic exams; increase in suicide risk as assessed by the C-SSRS; clinically significant changes in urological symptoms (including retention) as measured by the AUA-SI; and growth and development in adolescents assessed via physical exam and endocrine laboratory assessments.
次要结局
- Percent change in monthly seizure rate recorded at baseline (in the antecedent studies) compared to each 4-week assessment period in the treatment period in X-TOLE4.
- Proportion of responders (subjects experiencing ≥50% reduction in seizure frequency from baseline) in each consecutive 4-week assessment period of the treatment period of the OLE study
- Change in CGI‑S and PGI-S scores over time.
- Change in the QOLIE-31 over time.
研究者
Daniela Nenciu
Scientific
Xenon Pharmaceuticals Inc.