Position paper of a German interdisciplinary round table on future designs of trials on adjunctive treatment with antiseizure drugs

Purpose Current trials on adjunctive treatment with antiseizure drugs often do not reveal results which are relevant for clinical practice. Method Therefore, an interdisciplinary group of German experts discussed a new framework for future antiseizure drug (ASD) trials in adults. This group included members of the executive board of the German Society of Epileptology, of the German institutes for health technology assessment (HTA), of patient organizations and of drug manufacturers. Agreement was reached by consensus decision making after intensive discussion of the findings of a narrative review of the current literature. Results The group jointly recommends that ASD trials in adults should be based on and include relevant patient groups, e.g. elderly patients and patients with relevant co-morbidities, should adopt a study duration of at least 12 months, should avoid placebo arms, should include active comparators of clinical relevance, may be designed as open label trials with blinded outcome measurements, should focus on patient relevant outcomes that reflect the impact of benefits and harms of treatments on daily living, such as seizure freedom and seizure severity as well as retention rate, functional outcomes and quality of life as compound measures, and should avoid arbitrary and non-sensitive primary endpoints such as dichotomized changes in seizure frequency. Conclusions This paper focused on improved head-to-head trials on adjunctive treatment with antiseizure drugs. The group welcomes any further work and discussion to enhance future studies which can be applied to the entire spectrum of potentially meaningful study populations and outcomes.