Why are we doing this study? Epilepsy is very common in infants diagnosed with tuberous sclerosis complex (TSC) and often very difficult to treat. This study tests if sirolimus, a medication used in older children and adults with TSC, is safe and effective in preventing epilepsy in infants with TSC before seizures have a chance to start.

Who can participate in this study? Infants 0 to 6 months old who are diagnosed with TSC and have no history of seizures are eligible. The infant also cannot have been treated with anti-seizure medications before enrolling.

How many study visits are required? Each participant will have 7-8 study visits over 2 years. Some study visits can be done via telemedicine.

Where can I participate in the study? There are currently 8 study sites in the United States. More sites are expected to be added later in 2022.

What does it cost to be in the study? There is no compensation for participation in this study. However, funds to help pay for travel expenses are available.

For more information: Visit the study site or contact Molly Griffith, TSC-STEPS Project Manager, at 513-636-9669 or info@tscsteps.org.