RecruitingPhase 2Drug trialStopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention StudyThis trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants. This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).