A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study With Open-Label Extension Phase of Lorcaserin as Adjunctive Treatment in Subjects With Dravet Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Eisai Inc.
- 入组人数
- 22
- 试验地点
- 30
- 主要终点
- Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period
研究概览
简要总结
The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria to be included in this study:
- •Male or female, age 2 years and older at the time of informed consent
- •Diagnosis of epilepsy with Dravet syndrome
- •Has at least 4 convulsive seizures during the 4 weeks of baseline
- •Current treatment with antiepileptic drugs must be stable for at least 4 weeks before screening, and be expected to remain stable throughout the study
排除标准
- •Participants who meet any of the following criteria will be excluded from this study:
- •Use of lorcaserin within 4 weeks before screening, or any history of it being discontinued due to lack of efficacy or adverse reactions
- •Use of fenfluramine within 2 months before screening, any history of lack of fenfluramine efficacy, or any history of valvulopathy at baseline with history of fenfluramine use
- •Recent or concomitant use of serotonergic medications or monoamine oxidase inhibitors
- •Presence of progressive central nervous system disease other than Dravet syndrome
研究组 & 干预措施
Lorcaserin (Core Study and Open-label Extension Phase)
Participants will be randomized to receive lorcaserin administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to less than (<) 20, 20 to <40, and greater than or equal to (>=) 40 kilogram (kg) will be 5, 10, and 20 milligram per day (mg/day) respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.
干预措施: Lorcaserin (Drug)
Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
Participants will be randomized to receive lorcaserin matching placebo administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to <20, 20 to <40, and >=40 kg will be 5, 10, and 20 mg/day respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.
干预措施: Placebo (Drug)
Placebo (Core Study) + Lorcaserin (Open-label Extension Phase)
Participants will be randomized to receive lorcaserin matching placebo administered as an oral suspension, twice daily for 14 weeks during the core treatment period. Dose will be based on body weight as follows: target dose for participants weighing 10 to <20, 20 to <40, and >=40 kg will be 5, 10, and 20 mg/day respectively. Based on clinical response and tolerability and within 2 weeks of treatment, dose can be increased up to 10, 20 mg/day for participants weighing 10 to <20, 20 to <40 kg respectively. Participants completing the core treatment period will enter a 12-week extension phase and will receive lorcaserin.
干预措施: Lorcaserin (Drug)
结局指标
主要结局
Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period
时间窗: Baseline up to Week 14
Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. Percent change from baseline was calculated as: (\[post-baseline value minus the baseline value\] / baseline value) \*100.
次要结局
- Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline(Baseline up to Week 14)
- Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period(Baseline up to Week 14)
- Core Study: Plasma Concentrations of Lorcaserin(Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dose)
- Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18))