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

Inclusion Criteria:

   1. 0-6 months of age at the time of enrollment (subject must be <7 months of
   chronological age at time of randomization and treatment initiation). Corrected age
   must be at least 39 weeks (calculated by subtracting the number of weeks born before
   40 weeks gestation from the chronological age).

   2. Has a confirmed diagnosis of TSC based on established clinical or genetic criteria

Exclusion Criteria:

   1. Prior history of seizures (clinical or electrographic) at the time of enrollment or
   identified on baseline EEG.

   2. Has been treated in the past or is currently being treated at the time of enrollment
   with conventional anticonvulsant medications (AEDs), systemic (oral) mTOR inhibitors
   (such as rapamycin, sirolimus, or everolimus), ketogenic-related special diet, or
   another anti-seizure therapeutic agent, device, or procedure.

   3. Has taken any other investigational drug as part of another research study, within 30
   days prior to the baseline screening visit.

   4. Has a significant illness or active infection at the time of the baseline screening
   visit

   5. Has a history of significant prematurity, defined as gestational age <30 weeks at the
   time of delivery, or other significant medical complications at birth or during the
   neonatal period that other than TSC would convey additional risk of seizures or
   neurodevelopmental delay (i.e. HIE, severe neonatal infection, major surgery,
   prolonged ventilatory or other life-saving supportive care or procedures).

   6. Abnormal laboratory values at baseline (i.e., renal function, liver function, or bone
   marrow production) that are in the opinion of the investigator clinically significant
   and may jeopardize the safety of the study subject.

   7. Prior, planned or anticipated neurosurgery within 3 months of the baseline visit

   8. Has a TSC-associated condition for which mTOR treatment is clinically indicated (i.e.
   SEGA or AML).

   9. Subjects who are, in the opinion of the investigator, unable to comply with the
   requirements of the study.