RAPID VERSUS SLOW WITHDRAWAL OF ANTIEPILEPTIC MONOTHERAPY IN TWO-YEAR SEIZURE-FREE ADULTS PATIENTS WITH EPILEPSY (RASLOW) STUDY: A PRAGMATIC MULTICENTRE, PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY. - RASLOW

AZIENDA OSPEDALIERA BIANCHI-MELACRINO-MORELLI0 个研究点目标入组 350 人开始时间: 2021年9月30日最近更新: 2021年10月8日

适应症

试验速览

暂无简介。

•1)Age at inclusion 18+ years;
•2)Diagnosis of epilepsy (according to ILAE 1989 criteria);
•3)Age at epilepsy onset of 16 years or older;
•4)Seizure freedom for at least 2 years;
•5)Current treatment with one of the AEDs available for monotherapy available in Italy (carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide);
•6)Ability to understand and comply with the study requirements and to give written informed consent;
•7)Current drug is the active principle contributing to the achievement of seizure remission regardless of the indication and the tolerability profile;
•8)Absence of any contraindication and special warning for the current antiepileptic drug.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1)Inability to understand the aims or modalities of the study;
•2)Current pregnancy or plans to become pregnant during withdrawal period (e.g. who are not post menopausal, surgically sterile, or using inadequate birth control);
•3)History of seizure relapse after discontinuation of treatment;
•4)History of psychogenic non-epileptic seizures (PNES);
•5)History of status epilepticus;
•6)Poor compliance with previous treatments;
•7)Experimental treatments in previous 3 months;
•8)Men unable to practice contraception for the duration of the treatment.

发起方

AZIENDA OSPEDALIERA BIANCHI-MELACRINO-MORELLI