An Open-Label Extension, One-Year, Safety, and Efficacy Study of SPN-817 in Adults With Focal Onset Seizures
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
详细描述
This is a Phase 2b, multicenter, open-label extension, one-year, safety, tolerability, and efficacy study in adults who previously completed an applicable double-blind SPN-817 clinical study. This study will include a double-blind Dose Titration/Bridging Period of 8-10 weeks in which SPN-817 will be titrated to the participant's maximum tolerated dose based on response. Following the Dose Titration/Bridging Period, participants will enter an Open Label Extension (OLE) Period of 42-44 weeks. When participants finish the OLE Period, they will initiate a Tapering Period (up to 4 weeks) followed by an End-of-Tapering Period video contact (VC) after the last dose of study drug. The duration of study treatment before starting the 4-week Tapering Period will be one year (52 weeks).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed antecedent SPN-817 double-blind study
- •Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs
排除标准
- •Has current nonepileptic events that could be confused by the participant and/or study staff as epileptic seizures
- •Has any suicidal behavior or suicidal ideation related to Item 4 (active suicidal ideation with some intent to act without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) based on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessments in the antecedent study and at Visit 1 or more than one lifetime suicide attempt.
研究组 & 干预措施
SPN-817
SPN-817, bid
干预措施: SPN-817 (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: Week 1-Week 52
The percent of participants who took at least one dose of SPN-817 and reported at least one adverse event during the 1-year SPN-817 Treatment Period
次要结局
- Proportion of participants experiencing seizure freedom(Baseline and Treatment Period (Week 1-52))
- Percentage of seizure-free days over the 1-year SPN-817 Treatment Period(Week 1-Week 52)
- Percent change (PCH) from baseline in quantifiable focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period(Baseline and Treatment Period (Week 1-52))
- Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline(Baseline and Treatment Period (Week 1-52))