NCT02962414Active, not recruitingPhase 3
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
An Open-label, Multi-center Long-term Safety Roll-over Study in Patients With Tuberous Sclerosis Complex (TSC) and Refractory Seizures Who Are Judged by the Investigator to Benefit From Continued Treatment With Everolimus After Completion of Study CRAD001M2304.
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 206 (actual)
- First submitted
- 9 Nov 2016
- Start date
- 23 Aug 2017
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Epilepsy
- NCT number
- NCT02962414
- EU CT number
- 2024-516746-19-00
- EudraCT number
- 2016-002977-37
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 206
- From 23 Aug 2017 to the primary completion date, 30 Dec 2026
- 59 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country.
Other
- Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study
Who the study is looking for
- 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.
Age in the registry: 2 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (59)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.