Abstracts

Patients who volunteer for phase II and phase III clinical trials can gain access to investigated drugs long before these compounds are approved by the FDA. Patients participating in double blind, placebo-controlled trials of new medications are invited to partake in an open label extension study. Patients are openly given the active medication at this stage, regardless of their assignment in the initial trial, as long as the study permits. In order to determine if the open label extension phase has an impact on patient enrollment, we surveyed study participants who are currently participating in open label extension trials at our epilepsy center., All epilepsy patients who are currently participating in one out of 6 phase II or III trials at the Barrow Neurological Institute were included in the study. Questionnaires were administered to patients during their clinic visits or via email. Participating patients were asked questions regarding how open-label extension trials impacted their decision on participation and continuation in a study. In addition, patients were asked to rate their reasons on a 1-5 scale (5 being the most influential) why they would remain in the study in case of potential adverse events or no benefit in the initial placebo-controlled phase., All 41 patients replied to questionnaires. The median age of patients was 32, ranging from 19 to 64 years old. Almost two-third of them were female (68% compared to 32% of males). Thirty-seven of the 41 study participants (90%) answered that they decided to participate in a trial because of the offered open label extension phase. Ninety-Five percent (35 out of 37) admitted that they would have not participated in a research trial if an open label extension had not been offered. Despite 56% (23 out of 41) of patients experienced medication related adverse events (AEs), 87% of them participated in the open label extension phase. All the patients who experienced little or no medication related AEs also proceeded to an open extension. Even though 15 out of 41 patients experienced no significant seizure improvement during the initial placebo controlled phase, all of them participated in the open extension phase. The majority of the patients (83%) identified that the available open label extension phase was one of most influential reasons for remaining in clinical trials (X= 4.2)., Open label extension phase is an important and motivating factor why patients would initially participate in clinical trials. Regardless of success of the initial placebo controlled phase, the majority of patients would participate in an open label extension phases. Thus, offering open label phase could significantly increase the patient recruitment in the early phase of clinical trials.,