Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Inclusion Criteria:

   1. less than or equal to 6 months of age

   2. No history of seizures or infantile spasms, or evidence of subclinical electrographic
   seizures on a previous video EEG

   3. Meet genetic or clinical diagnostic criteria for TSC, the latter based on current
   recommendations for diagnostic evaluation, such as physical exam, neuroimaging,
   echocardiogram

Exclusion Criteria:

   1. Is greater than 6 months of age

   2. Has not been diagnosed with TSC

   3. History of seizures or infantile spasms, or evidence of subclinical electrographic
   seizures on a previous video EEG

   4. Has received any anticonvulsant medication including vigabatrin, other anti-seizure
   therapeutic agent including cannabidiol

   5. Has received an oral mTOR inhibitor such as everolimus or sirolimus

   6. Has taken an investigational drug, including but not limited to cannabidiol, as part
   of a research study 30 days prior to enrollment, or plans on taking an investigational
   drug at any time during the duration of the study

   7. Is currently enrolled, or plans on enrolling at any time during the duration of the
   study, in an experimental behavioral early intervention study

   8. Has a history of being born prematurely (born less than <30 weeks gestation at the
   time of delivery)