Double-blind randomized trial comparing efficacy, safety and tolerance between Levetiracetam monotherapy and Valproic acid monotherapy in children with newly diagnosed epilepsy - LEVVPA

niversity Medical Centre Groningen0 个研究点开始时间: 2012年9月6日最近更新: 2014年1月27日

研究概览

暂无简介。

•- Children of either sex from age 2 until (and including) age 15 years with weight between 13 and 60 kilograms
•- New but confident diagnosis of epilepsy made during the last year
•- According to the treating physician initiation of antiepileptic medication is indicated
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 200
•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

•- Weight (corrected for length) >+2SD above average as defined in the ‘Groeidiagrammen’ of TNO (2010)
•- Treatable underlying cause of epilepsy (e.g. GLUT1-deficiency syndrome)
•- Serious pre-existing behavioural disturbances (according to clinician’s judgment) or serious psychiatric disorders requiring hospitalization or medication
•- Uncountable seizures (clusters) or history of convulsive status epilepticus or mitochondrial disease (based on clinical characteristics or laboratory tests)
•- Earlier treatment with any other AED for seizures, other than emergency treatment, in the year before inclusion
•- Earlier treatment with LEV or VPA for any indication at any time
•- Participation in another clinical trial with an investigational drug or device within 12 weeks of inclusion, or at any time during this study
•- Known presence or history of allergy to the components of LEV or other pyrrolidine derivates or VPA
•- Any known disorder or condition that may interfere with the absorption, distribution, metabolisation or excretion of drugs (e.g. end stage renal disease, patients on dialysis, patients with hepatic disease, etc.)
•- Pregnancy or at risk of becoming pregnant (in case of active sexual life adequate contraception is obligatory)
•- Presence of progressive cerebral disease, any other progressively degenerative neurological disease or cerebral tumours with signs of progression

发起方

niversity Medical Centre Groningen