A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Subjects With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 27
- 主要终点
- Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10
研究概览
简要总结
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs). The study will also evaluate the effectiveness of ganaxolone in females with catamenial epilepsy.
Catamenial epilepsy refers to a relationship between seizure frequency and a woman's menstrual cycle, where the number of seizures increases around the time of a woman's menstrual cycle.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ganaxolone
active study drug
干预措施: Ganaxolone (Drug)
non-active drug
placebo
干预措施: Placebo (Other)
结局指标
主要结局
Mean Weekly Log-transformed Seizure Frequency During Weeks 1 Through 10
时间窗: Week 1 through Week 10
Weekly seizure frequency, analyzed as mean weekly log-transformed seizure frequency \[including partial-onset seizures (POS) with or without secondary generalization, but not non-motor simple partial seizure (SPS)\] during Weeks 1 through 10.
次要结局
- Number of Responders During Weeks 3 Through 10(Baseline and at Week 3 through Week 10)
- Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10(Baseline and at Week 1 through Week 10)
- Number of Responders During Weeks 1 Through 10(Baseline and at Week 1 through Week 10)
- Number of Seizure-free Participants Up to Week 2(Up to Week 2)
- Number of Seizure-free Days During Week 1 Through 10(Week 1 through Week 10)
- Mean Weekly Log-transformed Seizure Frequency During Weeks 3 Through 10(Week 3 through Week 10)
- Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10(Baseline and at Week 3 through Week 10)
- Percent Change From Baseline in Mean Weekly Seizure Frequency During Weeks 3 Through 10(Baseline and at Week 3 through Week 10)
- Change From Baseline in Mean Weekly Seizure Frequency During Weeks 1 Through 10(Baseline and at Week 1 through Week 10)
- Mean Weekly Seizure Frequency for Each Week After Dosing During Weeks 1 to 10(Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10)
- Percent Change From Baseline in Mean Weekly Seizure Frequency by Subtype During Weeks 1 Through 10(Baseline and at Week 1 through Week 10)
- Number of Seizure-free Participants During Weeks 1 Through 10(Week 1 through Week 10)
- Number of Seizure-free Participants During Weeks 3 Through 10(Week 3 through Week 10)
- Number of Seizure-free Days Up to Week 2(Up to Week 2)
- Number of Seizure-free Days During Week 3 Through 10(Week 3 through Week 10)