Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment

Key Inclusion Criteria:

Patient is currently enrolled in the Novartis-sponsored EXIST-3 study, receiving everolimus, and has fulfilled all its requirements
Patient is currently benefiting from treatment with everolimus, as determined by the Investigator.
Patient has demonstrated compliance, as assessed by the Investigator,with the parent study protocol requirements.
Patient is willing and able to comply with scheduled visits and treatment plans.
Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study.

Key Exclusion Criteria:

Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study
Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country.
Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose of seizure control.