Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study

Summary

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).

Timeline

Start

2021-10-13

Primary completion

2026-06-30

Completion

2027-06-30

Drugs

Indications