A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Response Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 67
- 主要终点
- Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
研究概览
简要总结
This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension).
The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures.
The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Weight at least 40 kg
- •A diagnosis of partial epilepsy according to the International League Against Epilepsy's Classification of Epileptic Seizures. Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history)
- •Have uncontrolled partial seizures despite having been treated with at least 1 AED within approximately the last 2 years
- •During the 8-week baseline period, subjects must have at least 8 partial seizures including only simple partial seizures with motor component, complex partial seizures, or secondarily generalized seizures without a seizure-free interval of greater than 25 days any time during the 8 weeks baseline. Subjects must have at least 3 of these partial seizures during each of the two consecutive 4-week segments of the baseline period
- •Currently on stable antiepileptic treatment regimen.
排除标准
- •A history of nonepileptic or psychogenic seizures
- •Presence of only nonmotor simple partial seizures or primary generalized epilepsies
- •Presence or previous history of Lennox-Gastaut syndrome
- •An active CNS infection, demyelinating disease, degenerative neurologic disease, or any CNS disease deemed to be progressive during the course of the study that may confound the interpretation of the study results
- •Any clinically significant psychiatric illness, psychological, or behavioral problems that, in the opinion of the Investigator, would interfere with the subject's ability to participate in the study
- •History of alcoholism, drug abuse, or drug addiction within the past 2 years
- •History of status epilepticus within 3 months of Visit 1
- •A "yes" answer to Question 1 or 2 of the C-SSRS (Baseline/Screening version) Ideation Section in the past 6 months or a "yes" answer to any of the Suicidal Behavior Questions in the past 2 years
- •More than 1 lifetime suicide attempt
- •Participation in any other trials involving an investigational product or device within 30 days of screening (or longer, as required by local regulations)
- •A history of any previous exposure to YKP3089
研究组 & 干预措施
YKP3089 Low Dose
YKP3089 Low Dose
干预措施: YKP3089 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
YKP3089 Medium Dose
YKP3089 Medium Dose
干预措施: YKP3089 (Drug)
YKP3089 High Dose
YKP3089 High Dose
干预措施: YKP3089 (Drug)
结局指标
主要结局
Percent Change From Baseline in Partial-onset Seizure Frequency Per 28 Days
时间窗: baseline and 18 weeks
Percent change in complex partial and/or secondarily generalized and/or simple partial motor seizure frequency per 28 days (average 28-day seizure rate) in each treatment group during the double-blind period relative to the pretreatment baseline.
次要结局
- 50% Responder Rate(18 weeks)