Add-on fenfluramine in Lennox Gastaut epilepsy

Z Leuven0 个研究点开始时间: 2015年11月26日最近更新: 2016年8月8日

试验速览

暂无简介。

•- Electro-clinical epilepsy syndrome compatible with Lennox Gastaut syndrome
•Minimum requirements (based on ILAE epilepsydiagnosis.org)
•- multiple seizure types including in any case tonic seizures
•- EEG shows slow spike waves and abnormal background
•- abnormal cognitive development
•- MRI compatible with Lennox Gastaut epilepsy : no progressive disease
•- Drug resistant :
•- at least 4 documented seizures in the last 4 weeks before inclusion
•(minimum 4 seizures in at least 2 separate weeks)
•Seizure types eligible for inclusion are : generalized tonic-clonic seizures GTC , tonic seizures TS , atonic seizures AS or clearly recognizable focal seizures FS.
•- on >= 2 AEDs (including VNS) during the 4 weeks before inclusion
•(no changes in treatment before inclusion and during the trial)
•- Age between 3 and 18 years
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•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

•- Known clinical cardiovascular abnormalities (including valvular problems, shunts, pulmonary hypertension, exercise intolerance)
•- Any cardiac ultrasound/ECG abnormalities at baseline
•- Weight below percentile 3 for age at baseline

发起方

Z Leuven