Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Darcy Krueger
64 participants
Oct 13, 2021
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
The investigational drug product to be used in this study is sirolimus, provided in oral suspension.
Matching placebo
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05104983