Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With Focal Onset Seizures (FOS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The occurrence of serious treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.
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
盲法说明
For participants who enroll directly from Study NBI-921352-FOS2021, the study will include a Blinded Dose Conversion Period (1 week) before proceeding to the Open-Label Treatment Period.
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provided informed consent.
- •Completed 11 weeks of treatment in Study NBI-921352-FOS
- •Stable treatment with at least 1 but not more than 4 antiseizure medicines.
排除标准
- •Have developed any other disorder for which the treatment takes priority over the treatment of focal onset seizure or is likely to interfere with study treatment or impair treatment compliance.
研究组 & 干预措施
NBI-921352 Treatment
Treatment for up to 107 weeks.
干预措施: NBI-921352 (Drug)
结局指标
主要结局
The occurrence of serious treatment-emergent adverse events (TEAEs)
时间窗: Through Week 111
次要结局
未报告次要终点