Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02962414 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study of Tuberous Sclerosis Complex, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
- 20
- Study locations
NCT02962414: Active Phase 3 study of Tuberous Sclerosis Complex, sponsored by Novartis Pharmaceuticals.
NCT02962414 is a Phase 3 study of Tuberous Sclerosis Complex that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 206 participants, above the 132-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02962414, a Phase 3 study of Tuberous Sclerosis Complex, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The patients will be followed continuously for tolerability (i.e adverse events, serious adverse events)
Conditions Studied
Interventions
- DRUG everolimus
Study Locations (20)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Ghent
- Novartis Investigative Site - Leuven
California
- David Geffen School of Medicine at UCLA - Los Angeles
- UCSF Benioff Children s Hospital - Oakland
- Rady Children s Hospital - San Diego
Texas
- Texas Scottish Rite Hos for Child - Dallas
- Texas Childrens Hospital - Houston
Arizona
- TGen APNNA - Phoenix
Colorado
- University of Colorado School of Medicine - Aurora
Connecticut
- Connecticut Childrens Medical Cntr - Hartford
Illinois
- University of Chicago Medical Center - Chicago
Minnesota
- Minnesota Epilepsy Group - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2027-08-13 |
| Phase | Phase 3 |
What the registry record for NCT02962414 still lists
NCT02962414 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, above the 132-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (56% higher).
The record links to 1 condition, with Tuberous Sclerosis Complex appearing as the primary indexed condition, and to 1 intervention - of which everolimus is the first listed.
NCT02962414 names 20 study sites across 14 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT02962414 about?
NCT02962414 is a clinical study titled "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". 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 co...
What is the current status of trial NCT02962414?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2017-06-08. Estimated completion is 2027-08-13.
What conditions does trial NCT02962414 study?
This clinical trial studies the following conditions: Tuberous Sclerosis Complex.
What interventions are being tested in trial NCT02962414?
The interventions under investigation include: everolimus (DRUG).
Who is sponsoring clinical trial NCT02962414?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02962414 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tuberous Sclerosis Complex
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02962414's enrollment target sits among peer trials
206 3rd of 8 higher than 6 of 8 other Tuberous Sclerosis Complex trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberous Sclerosis Complex trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
RECRUITING · Phase 2
-
Tuberous Sclerosis Complex and Lymphangioleiomyomatosis Pregnancy Registry (TSC-LAM Registry)
RECRUITING
-
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution
ACTIVE NOT RECRUITING · Phase 4
-
Feasibility of [11C]Acetate-PET in LAM and TSC
ACTIVE NOT RECRUITING · Phase 1
-
Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex
COMPLETED · NA
-
Tuberous Sclerosis Complex Natural History Study: Renal Manifestations
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03373968 · 206 participants · Phase 2
Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study
- NCT03550391 · 206 participants · Phase 3
Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
- NCT04757116 · 206 participants · NA
Post-Market Study to Assess iTind Safety in Comparison to UroLift
- NCT05675865 · 206 participants · NA
Cryoablation for Monomorphic Ventricular Tachycardia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI