Status: Recruiting
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
This 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).
Participants needed: 64
Trial details
Phase: Phase 2Age: 1-6Biological sex: AllType: InterventionalSponsor: Darcy KruegerUpdated: Jan 22, 2026Locations: 11
Eligibility criteria
0-6 months of age at the time of enrollment (subject must be <7 months of chrono... [+1]
Prior history of seizures (clinical or electrographic) at the time of enrollment... [+8]