For Healthcare Professionals

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


About the study

The purpose of this study is to evaluate the long-term safety in patients with TSC and refractory seizures who are currently receiving everolimus treatment in the Novartis-sponsored EXIST-3 study and who are determined to be benefiting from continued treatment as judged by the investigator at the completion of EXIST-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Key Inclusion Criteria:

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


Key Exclusion Criteria:

  1. Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study
  2. Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country.
  3. 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.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Tuberous Sclerosis Complex

Age (in years)

2 - 65


Phase 3

Participants needed


Est. Completion Date

Aug 13, 2027

Treatment type



Novartis identifier


Study number


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