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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 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.

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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

Conditions Studied

Tuberous Sclerosis Complex

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

1,375 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, categorized as Phase 3. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 132-participant average among 8 other Tuberous Sclerosis Complex trials with a reported enrollment target (56% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.