Abstracts

Rationale: In spite of the marketing of numerous new antiepileptic drugs (AED) the percentage of drug-resistant epilepsies has remained almost unchanged. We wondered whether the design of the usual phase II and III randomized controlled trials covers an acceptable percentage of AED-resistant epilepsy patients. Methods: We consecutively collected adult out-patients with drug-resistant epilepsies according to the recent ILAE classification. We assessed whether patients would have been recruitable for the last five phase II and III trials that have been performed at our center. Results: We identified 216 patients. Fourteen (7.4%) would have fulfilled the inclusion criteria of all five studies without meeting exclusion criteria. The major exclusion reasons were: 1. Treatment with enzyme-inducing AEDs (47.2%) 2. Too few seizures per definite periods in spite of AED resistance (46.3%) 3. EEG signs for generalized epileptogenesis (31.5%) 4. Intellectual disability or legal representatives (29.6%) 5. Long distance between home and center that prevents frequent visits as required by the study protocol (27.3%) Discussion: Due to selective criteria concerning potential study participants and limiting inclusion and exclusion factors of clinical AED trials only a small fraction of AED-resistant epilepsy patients is suitable. When new AEDs have passed such trials and are introduced we have no information about potential efficacy and tolerability in more than 90% of our patients with AED-resistant epilepsies. Conclusions: Our findings suggest that the markedly impaired consideration of AED-resistant epilepsies by pivotal AED trials may be one reason for the disappointing efficacy data of many new AEDs after launch. Funding: Medical writing was funded by an unrestricted grant provided by UCB. UCB was not involved in the study design, the collection, analysis, and interpretation of the data gathered, and the writing of the study report of the manuscript.