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
Condition(s) studied
Investigational drug(s) / intervention(s)
everolimus: everolimus, 2mg dispersible tablets
Study summary
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
Eligibility
Primary outcome measure(s)
- Occurances of adverse events and serious adverse events — Day 1 up to approximately 10 years
The patients will be followed continuously for tolerability (i.e adverse events, serious adverse events)
Trial sites (67)
| Facility | City | Region | Status |
|---|---|---|---|
| TGen APNNA | Phoenix | Arizona | |
| David Geffen School of Medicine at UCLA | Los Angeles | California | |
| UCSF Benioff Children s Hospital | Oakland | California | |
| Rady Children s Hospital | San Diego | California | |
| University of Colorado School of Medicine | Aurora | Colorado | |
| Connecticut Childrens Medical Cntr | Hartford | Connecticut | |
| University of Chicago Medical Center | Chicago | Illinois | |
| Minnesota Epilepsy Group | Saint Paul | Minnesota | |
| Atlantic Health Morristown MC | Morristown | New Jersey | |
| Cinn Children Hosp Medical Center | Cincinnati | Ohio | |
| Oregon Health Sciences University | Portland | Oregon | |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | |
| Texas Scottish Rite Hos for Child | Dallas | Texas | |
| Texas Childrens Hospital | Houston | Texas | |
| Novartis Investigative Site | Sydney | New South Wales | |
| Novartis Investigative Site | Nedlands | Western Australia | |
| Novartis Investigative Site | Brussels | Belgium | |
| Novartis Investigative Site | Brussels | Belgium | |
| Novartis Investigative Site | Ghent | Belgium | |
| Novartis Investigative Site | Leuven | Belgium | |
| Novartis Investigative Site | Vancouver | British Columbia | |
| Novartis Investigative Site | Cali | Valle del Cauca Department | |
| Novartis Investigative Site | Amiens | France | |
| Novartis Investigative Site | Bron | France | |
| Novartis Investigative Site | Lille | France | |
| Novartis Investigative Site | Marseille | France | |
| Novartis Investigative Site | Strasbourg | France | |
| Novartis Investigative Site | Budapest | Hungary | |
| Novartis Investigative Site | Bari | BA | |
| Novartis Investigative Site | Bologna | BO | |
| Novartis Investigative Site | Pavia | PV | |
| Novartis Investigative Site | Roma | RM | |
| Novartis Investigative Site | Siena | SI | |
| Novartis Investigative Site | Suita | Osaka | |
| Novartis Investigative Site | Shizuoka | Shizuoka | |
| Novartis Investigative Site | Okayama | Japan | |
| Novartis Investigative Site | Osaka | Japan | |
| Novartis Investigative Site | Guadalajara | Jalisco | |
| Novartis Investigative Site | Warsaw | Poland | |
| Novartis Investigative Site | Samara | Samara Oblast |
+ 27 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02962414 on ClinicalTrials.gov ↗ ← All trials in Italy