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Drug shows promise for Long-Term seizure control in rare disease

NCT ID NCT02962414

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study looks at the long-term safety of everolimus in people with tuberous sclerosis complex (TSC) who have seizures that are hard to control. Participants are already taking everolimus and benefiting from it in an earlier study. The goal is to see if the drug remains safe and helpful over a longer period. About 206 people are taking part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
everolimus
What this could lead to
If successful, this study could confirm that everolimus is safe and effective for long-term seizure control in people with tuberous sclerosis complex.
What could go wrong
This is an open-label roll-over study with no placebo group, so results may be biased. It only includes people already benefiting, so it may not reflect real-world outcomes for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

206 people

The number who actually took part.

Started

Aug 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Patient is currently enrolled in the Novartis-sponsored EXIST-3 study, receiving everolimus, and has fulfilled all its requirements * Patient is currently benefiting from treatment with everolimus, as determined by the Investigator. * Patient has demonstrated compliance, as assessed by the Investigator,with the parent study protocol requirements. * Patient is willing and able to comply with scheduled visits and treatment plans. * Written informed consent/adolescent assent obtained prior to enrolling into the roll-over study. Key Exclusion Criteria: * Patient has been permanently discontinued from everolimus study treatment in EXIST-3 study * Everolimus is approved for patients with TSC and refractory seizures and is reimbursed in the local country. * Patients who are receiving everolimus in combination with unapproved or experimental treatments for seizure control Anti-epileptic drug (AEDs) are allowed for the purpose of seizure control.

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Conditions

The condition(s) this trial relates to.

tuberous sclerosis tuberous sclerosis 1 visual epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberous sclerosis complex

Contacts and locations

Locations

  • Atlantic Health Morristown MC

    Morristown, New Jersey, 07962, United States

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cinn Children Hosp Medical Center

    Cincinnati, Ohio, 45229-3039, United States

  • Connecticut Childrens Medical Cntr

    Hartford, Connecticut, 06106, United States

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90005-1752, United States

  • Minnesota Epilepsy Group

    Saint Paul, Minnesota, 55102, United States

  • Novartis Investigative Site

    Sydney, New South Wales, 2031, Australia

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009, Australia

  • Novartis Investigative Site

    Brussels, 1090, Belgium

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Ghent, 9000, Belgium

  • Novartis Investigative Site

    Leuven, 3000, Belgium

  • Novartis Investigative Site

    Vancouver, British Columbia, V6H 3V4, Canada

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760032, Colombia

  • Novartis Investigative Site

    Amiens, 80054, France

  • Novartis Investigative Site

    Bron, 69677, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Marseille, 13885, France

  • Novartis Investigative Site

    Strasbourg, 67000, France

  • Novartis Investigative Site

    Budapest, 1145, Hungary

  • Novartis Investigative Site

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    Bologna, BO, 40139, Italy

  • Novartis Investigative Site

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    Siena, SI, 53100, Italy

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Shizuoka, Shizuoka, 4208688, Japan

  • Novartis Investigative Site

    Okayama, 7008558, Japan

  • Novartis Investigative Site

    Osaka, 5340021, Japan

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44280, Mexico

  • Novartis Investigative Site

    Warsaw, 04-730, Poland

  • Novartis Investigative Site

    Samara, Samara Oblast, 443095, Russia

  • Novartis Investigative Site

    Moscow, 119991, Russia

  • Novartis Investigative Site

    Moscow, 127412, Russia

  • Novartis Investigative Site

    Voronezh, 394024, Russia

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28009, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Seville, 41013, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    Bangkok, 10330, Thailand

  • Novartis Investigative Site

    Bangkok, 10400, Thailand

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Istanbul, Fatih, 34093, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Novartis Investigative Site

    Buckinghamshire, SL9 0RJ, United Kingdom

  • Novartis Investigative Site

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    Liverpool, L12 2AP, United Kingdom

  • Novartis Investigative Site

    London, SW17 0QT, United Kingdom

  • Novartis Investigative Site

    London, WC1N 3JH, United Kingdom

  • Novartis Investigative Site

    Sheffield, S10 2TH, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Rady Children s Hospital

    San Diego, California, 92123, United States

  • TGen APNNA

    Phoenix, Arizona, 85012, United States

  • Texas Childrens Hospital

    Houston, Texas, 77030, United States

  • Texas Scottish Rite Hos for Child

    Dallas, Texas, 75219, United States

  • UCSF Benioff Children s Hospital

    Oakland, California, 94609, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Colorado School of Medicine

    Aurora, Colorado, 80045, United States

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