A Phase 2, Multicenter, Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Who Completed Study LP352-201 and Are Candidates for Continuous Treatment for Up to 52 Weeks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 28
- 主要终点
- Treatment-emergent Adverse Events
研究概览
简要总结
The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.
详细描述
This Phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of LP352 in subjects with developmental and epileptic encephalopathy who completed Study LP352-201.
The study consists of a Screening Period (Day -1) and a 50-week open-label Treatment Period that includes a 15-day Up-titration Period (during which time subjects will titrate up to their highest tolerated doses) and an open-label Maintenance Period (48 weeks). The Treatment Period will be followed by a Down-titration/Taper Period (up to 15 days) and Follow-up Period (14 days after completion of down-titration). The starting dose of up-titration will be 6 mg TID. The target final maintenance doses are 6 mg TID, 9 mg TID, and 12 mg TID after a 15-day up-titration period, if tolerated.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-lactating female, age 12 to 65 years who have satisfactorily completed study LP352-201
- •Diagnosis of Dravet syndrome, Lennox-Gastaut syndrome, or other developmental and epileptic encephalopathy
- •The patient/parent/caregiver is able and willing to attend study visits, complete the diary and take study drug as instructed
排除标准
- •Had an SAE in Study LP352-201 that was definitely, probably, or possibly related to exposure to study drug
- •Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, pulmonary arterial hypertension or abnormal blood pressure
- •Has glaucoma, renal impairment, liver disease or any other medical condition that would affect study participation or pose a risk to the subject
- •Current or recent history of moderate or severe depression, anorexia nervosa, bulimia or at risk of suicidal behavior
- •Currently taking anorectic agents, monoamine oxidase inhibitors; serotonin agonists or antagonists including fenfluramine, atomoxetine, vortioxetine, or other medications for weight loss
- •Positive test result on the drug screen, except tetrahydrocannabinol (THC) for patients taking prescribed cannabidiol
研究组 & 干预措施
LP352, bexicaserin
Subjects will be titrated up to highest tolerated dose of LP352 during a 15-day period, followed by a 48-week maintenance period and a 15-day taper/down titration period.
干预措施: LP352, bexicaserin (Drug)
结局指标
主要结局
Treatment-emergent Adverse Events
时间窗: Baseline up to Week 52
Incidence and severity of treatment-emergent adverse events, including serious adverse events and adverse events leading to study discontinuation and clinically significant changes in vital signs, physical examination endpoints, clinical safety laboratory values and ECGs
Patient Health Questionnaire-9 Total Score and Question 9 Score
时间窗: Baseline up to Week 52
Severity Rating Scale: 0 - 27; higher scores indicate greater severity of depressive disorder
Columbia-Suicide Severity Rating Scale (C-SSRS) Response
时间窗: Baseline up to Week 52
Type of Suicidal Ideation, Intensity (1 - 5, with 5 being most severe), Suicidal Behavior
次要结局
- Percent Change from Baseline in Observed Countable Motor Seizure Frequency During the Treatment Period(Baseline to Week 50)
- Percent of Subjects with Countable Motor Seizure-free Days During the Treatment Period(Baseline to Week 50)
- Percent Reduction in Individual Seizure Type During the Treatment Period(Baseline to Week 50)
- Proportion of Subjects with > 50% Reduction in Total Seizures During the Treatment Period(Baseline to Week 50)
- Proportion of Subjects Requiring Rescue Medication During the Treatment Period(Baseline to Week 50)
- Percent Change from Baseline in the Number of Episodes of Status Epilepticus During the Treatment Period(Baseline to Week 50)
- LGS: Percentage Change from Baseline in the Frequency of Observed Drop Seizures Over the Treatment Period(Baseline to Week 50)
- Percentage Change from Baseline in Non-motor and Difficult to Count Seizures(Baseline to Week 50)