This study is testing if an oral liquid medicine called sirolimus can prevent or delay seizures in babies with Tuberous Sclerosis Complex (TSC). TSC is a genetic condition that can cause problems like epilepsy. Sirolimus works by targeting a pathway in the body called mTOR, which is overactive in TSC. This study is comparing sirolimus to a placebo (an inactive substance that looks like the real medicine) to see if sirolimus is safe and effective. We are looking for infants aged 1 day to 6 months old who have TSC. The main goals are to see how long it takes for seizures to start and to track any side effects, both measured at 12 months of age. The current recruitment status is unclear.

Study design

This is a Phase II study that is randomized, meaning participants are assigned to either sirolimus or placebo by chance. It is also double-blind, so neither you nor your doctor will know which treatment your baby is receiving. The study plans to enroll 64 participants.

What's involved

Not specified in the trial record.

Compensation

Not stated in the trial record.

Follow-up

The study will track seizure onset and adverse events until your baby is 12 months old.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.