Reasons for ineligibility for clinical trials of patients with medication resistant epilepsy

Abstract

Selection criteria for clinical trials for medication resistant epilepsy are used to limit variability and to ensure safety. However, it has become more challenging to recruit subjects for trials. This study investigated the impact of each inclusion and exclusion criteria on medication resistant epilepsy clinical trial recruitment at a large academic epilepsy center. We retrospectively identified all patients with medication resistant focal- or generalized-onset epilepsy who attended outpatient clinic over a consecutive 3-month period. We assessed each patient’s eligibility of trials with commonly required inclusion and exclusion criteria to evaluate the proportion of eligible patients and the most common reasons for exclusion. Among 212 patients with medication-resistant epilepsy, 144 and 28 patients met the criteria for focal- or generalized-onset epilepsy, respectively. Overall 9.4% (20) patients were eligible for trials (19 focal-onset and 1 generalized-onset). Most patients were excluded from the study due to insufficient seizure frequency (58% of focal-onset, 55% of generalized-onset). A small proportion of patients with medication-resistant epilepsy are eligible for trials based on common selection criteria. These eligible patients may not be representative of the general population of patients with medication-resistant epilepsy. Insufficient seizure frequency was the most common reason for exclusion.

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