KETASER01 protocol: What went right and what went wrong.
Anna RosatiManuela L'ErarioRoberto BianchiSara OlivottoDomenica Immacolata BattagliaFrancesca DarraPaolo BibanAnnibale BiggeriDolores CatelanGiacomo DanieliMaria Cristina MondardiniDuccio Maria CordelliAngela AmigoniElisabetta CesaroniAlessandra ConioPaola CostaMartina LombardiniRosanna MeleleoAlessandra PugiElena Eve TornaboniMarta Elena SantaroneRoberta VittoriniStefano SartoriCarla MariniFederico VigevanoMassimo MastrangeloSilvia Maria PulitanòFrancesca IzzoLucia FuscoPublished in: Epilepsia open (2022)
The KETASER01 study was prematurely halted due to low eligibility of patients and no successful recruitment. No conclusions can be drawn regarding the objectives of the study. Here, we discuss the KETASER01 results and critically analyze the reasons for its failure in view of future trials.