Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex

Inclusion Criteria:

less than or equal to 6 months of age
No history of seizures or infantile spasms, or evidence of subclinical electrographic seizures on a previous video EEG
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:

Is greater than 6 months of age
Has not been diagnosed with TSC
History of seizures or infantile spasms, or evidence of subclinical electrographic seizures on a previous video EEG
Has received any anticonvulsant medication including vigabatrin, other anti-seizure therapeutic agent including cannabidiol
Has received an oral mTOR inhibitor such as everolimus or sirolimus
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
Is currently enrolled, or plans on enrolling at any time during the duration of the study, in an experimental behavioral early intervention study
Has a history of being born prematurely (born less than <30 weeks gestation at the time of delivery)