Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants

This trial is comparing two drugs — rapamycin (an mTOR inhibitor) and vigabatrin (an anti-seizure medication) — to see which is better at preventing the symptoms of tuberous sclerosis complex (TSC) from developing in very young infants who have been diagnosed but have not yet had seizures. **You may be eligible if...** - Your infant is between 4 and 16 weeks old (corrected gestational age 44–56 weeks) - Your child has a confirmed diagnosis of tuberous sclerosis complex (TSC) - At least one area of abnormal brain tissue has been found on MRI - Your child has not yet had any seizures - Parents are willing and able to participate and give consent **You may NOT be eligible if...** - Your baby has already had seizures or received anti-seizure treatment - Your baby was born prematurely (gestational age below 44 weeks at enrollment) - Your baby weighs less than 3 kg - Your baby has a brain tumor requiring urgent surgery - Your baby has had a recent infection or surgery Talk to your doctor to see if this trial is right for you.