A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 880
- 试验地点
- 273
- 主要终点
- The adverse events
研究概览
简要总结
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.
详细描述
This is an Open Label Extension study of the following Phase 3 clinical studies: XPF-010-301 (X-TOLE2), XPF-010-302 (X-TOLE3), and XPF-010-303 (X-ACKT). This study will evaluate the long-term safety, tolerability, PK, and efficacy of XEN1101 in subjects with FOS or PGTCS for the treatment of seizures for up to 6 years. Subjects who successfully completed and did not terminate early from one of the antecedent studies (X-TOLE2, X-TOLE3, or X-ACKT) are eligible to participate in X-TOLE4.
Following enrollment into X-TOLE4, subjects will undergo a treatment period of up to 6 years, during which there will be a visit at 2-, 4-, and 13-weeks post-entry, with subsequent visits occurring at 13-week intervals during the first year, and then at 26-week intervals (with a telephone call in between) until dosing is completed.
Subjects will be initially assigned to XEN1101 as follows:
-
25 mg QD for subjects aged ≥18 years
-
For subjects aged ≥12 and <18 years
-
15 mg QD for those
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be properly informed of the nature and risks of the study and give informed consent in writing prior to entering the study (for adult subjects) and for adolescent subject's parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.
- •Subject must have successfully completed the double-blind treatment 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 adverse events (AEs) (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study.
- •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.
- •Subject is able to keep accurate seizure diaries.
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.
- •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.
研究组 & 干预措施
XEN1101 15 or 25 mg/day
XEN1101 15 or 25 mg/day
干预措施: XEN1101 (Drug)
结局指标
主要结局
The adverse events
时间窗: From the start of treatment in the open-label extension (OLE) study through 8 weeks after the last dose.
To assess the safety and tolerability of XEN1101
次要结局
- Change in Clinical Global Impression of Severity (CGI-S)(From baseline through the active extension treatment (Week 156).)
- Change in monthly seizure rate(From baseline through the active extension treatment (Week 156).)
- Proportion of responders(From baseline through the active extension treatment (Week 156).)
- Change in Quality of Life in Epilepsy Inventory (QOLIE-31)(From baseline through the active extension treatment (Week 156).)
- Change in Patient Global Impression of Severity (PGI-S)(From baseline through the active extension treatment (Week 156).)
- Change in monthly seizure rate(From baseline through the active extension treatment (Week 312).)
- Proportion of responders(From baseline through the active extension treatment (Week 312).)
- Change in Clinical Global Impression of Severity (CGI-S)(From baseline through the active extension treatment (Week 312).)
- Change in Patient Global Impression of Severity (PGI-S)(From baseline through the active extension treatment (Week 312).)
- Change in Quality of Life in Epilepsy Inventory (QOLIE-31)(From baseline through the active extension treatment (Week 312).)