NCT05159908已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of NBI-921352 as Adjunctive Therapy in Adult Subjects With Focal Onset Seizures (FOS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs
研究概览
简要总结
This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of providing consent and has completed the written informed consent.
- •Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) < 40 kg/m^
- •Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017) at least 18 months before screening.
- •History of uncontrolled seizures despite adequate treatment with at least 1 anti-seizure medication (ASM) for at least 18 months prior to screening.
- •Treatment with at least 1 but not more than 4 ASMs for at least 1 month before screening, during the baseline seizure diary data collection, and throughout the duration of the study.
- •Be able to keep accurate seizure diaries.
- •Documented seizure frequency in the baseline seizure diary of ≥8 countable focal seizures during the 8-week seizure baseline period.
排除标准
- •History of epilepsy with only nonmotor seizures without an observable component, psychogenic nonepileptic seizures, or primary generalized seizures.
- •Presence or previous history of developmental and/or epileptic encephalopathy.
- •Presence of seizure types other than FOS.
- •History of repetitive seizures within the 12-month period preceding study entry where the individual seizures cannot be counted.
- •Status epilepticus within the last 12 months before enrollment.
- •Any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 2 years before screening, a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt.
- •History or presence of any significant medical or surgical condition, lab value, or concomitant medication that would place the subject at increased risk.
- •A known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pre-treatment) QT interval corrected for heart rate.
- •Require use of rescue medication more than once per week.
- •Multiple drug allergies or a severe drug reaction to an ASM(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions.
- •An implanted responsive neurostimulator system (RNS).
研究组 & 干预措施
Placebo schedule
Placebo Comparator
Participant follows Placebo schedule (13 weeks)
干预措施: Placebo (Drug)
Dose schedule A
Experimental
Participant follows Dose schedule A (13 weeks)
干预措施: NBI-921352 (Drug)
Dose schedule B
Experimental
Participant follows Dose schedule B (13 weeks)
干预措施: NBI-921352 (Drug)
Dose schedule C
Experimental
Participant follows Dose schedule C (13 weeks)
干预措施: NBI-921352 (Drug)
结局指标
主要结局
Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs
时间窗: Through Week 15
NBI-921352 exposure-efficacy response relationship, defined as the slope of the relationship between reduction in monthly focal onset seizure frequency and plasma concentration at steady state
时间窗: Baseline to Week 11
次要结局
- Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period(Baseline and Weeks 4 to 11)
- Percentage of Participants with a ≥ 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period(Baseline and Weeks 1 to 11)
- Clinical Global Impression of Change (CGIC) Scores at Week 11(Week 11)
- Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period(Baseline and Weeks 1 to 11)
研究者
研究点 (1)
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