Anti-epileptogenic clinical trial designs in epilepsy: issues and options.

ABSTRACT: Although trials with anti-seizure drugs have not shown anti-epileptogenic or disease-modifying activity in humans, new compounds are on the horizon that may require novel trial designs. We briefly discuss the unique challenges and the available options to identify innovative clinical trial designs that differentiate novel anti-epileptogenic and disease-modifying compounds, preferably early in phase II, from current anti-seizure drugs. The most important challenges of clinical testing of agents for epilepsy prevention include having sufficient preclinical evidence for a suitable agent to proceed with a human trial of an anti-epileptogenic drug, and to demonstrate the feasibility of doing such a trial. Major challenges in trial design to assess agents for disease modification include the cho

SUBMITTER: Schmidt D 

PROVIDER: S-EPMC3996121 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature