EUCTR2018-001664-38-DE进行中（未招募）1 期
A proof of concept and assessment of maximal effect study with low dose Fenfluramine as add-on therapy in Myoclonic Astatic Epilepsy (Doose-Syndrome) - FFA-MAE
niversity Hospital Schleswig-Holstein (UKSH)0 个研究点目标入组 10 人开始时间: 2019年4月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of Doose syndrome
- •Age: 1 to 17 years.
- •Normal cognitive development before the onset of epilepsy and absence of organic cerebral abnormalities.
- •Onset of myoclonic, myoclonic-(atonic) astatic or atonic-astatic seizures, absences, status of „petit mal, generalized tonic clonic seizures; sometimes febrile seizures occur before the start of epilepsy.
- •Multiple seizure types (at least 2) including in any case myoclonic atonic seizures
- •at least 6 documented seizures in the last 4 weeks before inclusion
- •on >= 1AED during the 4 weeks before inclusion
- •Presence on EEG of biparietal theta background rhythm, and irregularly generalized spike wave, and polyspike wave
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any cardiovascular abnormality
- •Abnormal weight (below age specific 3rd percentile)
- •Cortical structural brain lesions.
- •Presence of severe and benign myoclonic epilepsy (SME, BME) in infancy and early childhood
- •Presence of cryptogenic Lennox-Gastaut syndrome, based on the ILAE definitions
- •Presence of atypical benign partial epilepsy/pseudo-Lennox-syndrome
- •Presence of other symptomatic / cryptogenic epilepsies (e.g. with a frontal lobe semiology).
- •Progressive neurodegenerative disease
- •certain drugs
研究者
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