Harden, C L; Perucca, E; Quigg, M; French, J; Herman, S
"De-standardizing aed therapy development: Translating 'translational' research into clinical trials" [Meeting Abstract]
Epilepsy currents 2011 2011; 11(1):-
- Summary: Clinical treatment trials for seizures disorders are usually consist of trying to enroll a patient population that has a high frequency of a specific seizure type, then blindly and randomly treating them with an antiseizure drug versus placebo and comparing seizure frequency before and after treatment. This study design is adequate to evaluate effectiveness to a limited extent for short-term oral medication treatment trials. However, epilepsy clinical investigators are often inspired by their patients to study other important outcomes including cognitive, behavioral and endocrine outcomes. Further, novel treatment approaches currently under development such as gamma-knife treatment for temporal lobe epilepsy and anti-inflammatory molecular interventions for intractable epilepsy require using different timelines and outcomes measures than standard antiseizure drug trials. Finally the influence of the basic science epilepsy researchers on clinical trials in humans is enormous yet the strategies of testing hypotheses derived in the lab to human clinical trials remains unsystematic and unsatisfying for investigators on both sides of the aisle. We will provide a forum for presenting several real and several proposed clinical trial designs that incorporate novel outcome measures and are informed by basic research. There will also be discussion and critique of the trials. Clinical investigators and especially basic science investigators are encourage to attend and to participate in the discussion The clinical trials under discussion will include a trial of cognitive preservation in temporal lobe epilepsy, testosterone levels and behavior alterations with antiseizure drugs, the trial design of using gamma-knife to treat temporal lobe epilepsy and a proposed approach to evaluating anti-inflammatory antiseizure treatments, incorporating such considerations as an appropriate study population and biomarkers for efficacy or toxicity. The presenters will be Drs. Quigg, Perucca and Harden. The discussion leaders will be Drs. Herman and French
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