Methodological issues associated with clinical trials in epilepsy

摘要: ABSTRACTIntroduction: despite methodological advances in epilepsy clinical trials, the proportion of patients reaching seizure-freedom has not substantially changed over years. We review main limitations current possible strategies to overcome these limits, and issues that need be addressed next future.Area covered: references were identified by PubMed search until March 2017 unpublished literature was searched on ClinicalTrials.gov. Add-on trials mainly involve refractory subjects, reducing overall response investigational drug. The inclusion subjects with earlier disease from less developed countries partially allowed overcoming this limitation, but introduced more random variability results. Monotherapy rise methodological, economical, ethical concerns different regulatory requirements European Union United States America. Newer trial designs, such as futility or ‘time-to-event’ des...