Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Efficacy of add-on FFA in Lennox Gastaut epilepsy: Number of responders and seizure free patients at each FFA dosage (0,2 or 0,4 or 0,8 mg/kg/day)
研究概览
简要总结
In this trial, the potential anti-epileptic effect of low dose fenfluramine in Lennox Gastaut epilepsy will be studied. An exploratory dose finding add-on trial is proposed. At baseline and at the end of the study, ECG and ultrasound of the heart will be performed as part of the safety follow up.
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
- 3 Years 至 18 Years（Child, 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
fenfluramine
Experimental : one armed open label study :
Add-on fenfluramine in refractory Lennox Gastaut patients. Starting dose 0.2mg/kg/day. In non-responders (<50% seizure frequency decrease), dose will be uptitrated every 4 weeks from 0,2 to 0,4 and max 0,8 mg/kg/day (max 30 mg). Total duration study and max exposure to the drug 20 weeks
干预措施: Fenfluramine (Drug)
结局指标
主要结局
Efficacy of add-on FFA in Lennox Gastaut epilepsy: Number of responders and seizure free patients at each FFA dosage (0,2 or 0,4 or 0,8 mg/kg/day)
时间窗: up to 20 weeks
次要结局
- Seizure frequency change per patient and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS))(20 weeks)
- Adverse events (cardiac and general)(20 weeks)
- Sleep quality : 10 point scale instrument to score sleep quality(20 weeks)
- CGI (clinical global impression) scale at last visit , by patient/caregiver and treating physician(20 weeks)
研究者
Lieven Lagae
Professor Paediatric Neurology
KU Leuven