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
Running, not enrolling · Phase 3
Conditions studied: Tuberous Sclerosis Complex
In brief
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
Key facts
- Study ID
- NCT02962414
- Run by
- Novartis Pharmaceuticals
- People needed
- 206
- Starts
- 2017-06-08
- Expected to finish
- 2027-08-13
- Last updated by the study team
- 2026-04-02
Who can join
Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- David Geffen School of Medicine at UCLA — Los Angeles, California, United States
- UCSF Benioff Children s Hospital — Oakland, California, United States
- Rady Children s Hospital — San Diego, California, United States
- University of Colorado School of Medicine — Aurora, Colorado, United States
- Connecticut Childrens Medical Cntr — Hartford, Connecticut, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Minnesota Epilepsy Group — Saint Paul, Minnesota, United States
- Atlantic Health Systems — Morristown, New Jersey, United States
- Cinn Children Hosp Medical Center — Cincinnati, Ohio, United States
- Oregon Health Sciences University — Portland, Oregon, United States
- Childrens Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Texas Scottish Rite Hos for Child — Dallas, Texas, United States
- Texas Childrens Hospital — Houston, Texas, United States
- Novartis Investigative Site — Sydney, New South Wales, Australia
- Novartis Investigative Site — Nedlands, Western Australia, 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, Canada
- Novartis Investigative Site — Cali, Valle del Cauca Department, Colombia
- Novartis Investigative Site — Amiens, France
- Novartis Investigative Site — Bron, France
- Novartis Investigative Site — Lille, France
- TGen APNNA — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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