The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome (FAST-DS) Project.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in blood oxygenation level in response to CO₂
研究概览
简要总结
This study investigates cerebrovascular reactivity (CVR) and functional brain connectivity in Dravet Syndrome (DS) patients with convulsive seizures. Using functional MRI (fMRI), we will define differences in brain responses to CO₂ changes before administration of the drug Fintepla (Baseline), with a library of healthy controls and with those obtained after administration of Fintepla (Day ~60). Changes in CVR and their relation to ventilatory responses will also be assessed during fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DS patients (with or without SCN1A pathogenic mutations)
- •Generalized convulsive seizures
排除标准
- •known cardiorespiratory, hepatic or renal disease, and/or
- •allergic reactions or other contraindications to fenfluramine and/or
- •on Stiripentol treatment, and/or
- •on serotonergic medications, and/or
- •contraindications to Midazolam anesthesia
- •taken the following drugs within 14 days: monoamine oxidase inhibitors (MAOIs), anti-depressants (Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and norepinephrine reuptake inhibitors (SNRIs), and Tricyclic antidepressants (TCAs)), St. John's Wort, Tryptophan, and Dextromethorphan
结局指标
主要结局
Change in blood oxygenation level in response to CO₂
时间窗: Baseline, Day ~60
Measures how much blood oxygenation level dependent (BOLD) signal changes in response to CO₂, using fMRI.
Change in speed of cerebrovascular response to CO₂
时间窗: Baseline, Day ~60
Measures how quickly the brain responds to CO₂ exposure during fMRI.
次要结局
- Change in breathing response to CO₂(Baseline, Day ~60)
研究者
Samden Lhatoo
Professor
The University of Texas Health Science Center, Houston