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ACTIVE NOT RECRUITING 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

NCT02962414 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 206 participants
Start Date 2017-06-08
Est. Completion 2027-08-13
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02962414

The ClinicalTrials.gov registry entry for NCT02962414 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02962414 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02962414?

The interventions under investigation include: everolimus (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02962414?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial