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Summary

for people ages 2–65 (full criteria)
at Oakland, California and other locations
study started
estimated completion:

Description

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

Official Title

An Open-label, Multi-center Long-term Safety Roll-over Study in Patients With Tuberous Sclerosis Complex (TSC) and Refractory Seizures Who Are Judged by the Investigator to Benefit From Continued Treatment With Everolimus After Completion of Study CRAD001M2304.

Details

This is a multi-center, open label study to evaluate the long term safety of everolimus in patients with TSC and refractory seizures currently being treated in the Novartis-sponsored study EXIST-3 study and are judged by their parent study investigator as benefiting from the current study treatment. The study is expected to remain open for approximately 10 years (or until 31-Dec-2022 in the UK) from First Patient First Visit (FPFV).

Patients will continue to be treated in this study until they are no longer benefiting from their everolimus treatment as judged by the Investigator or until one of the protocol defined discontinuation criteria is met or everolimus becomes commercially available according to local regulations.

Keywords

Tuberous Sclerosis Complex Everolimus TSC Refractory seizure Roll over study Long term safety PASS Sclerosis Seizures Tuberous Sclerosis Sirolimus

Eligibility

For people ages 2–65

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.

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    Oakland, California, 94609, United States
  • TGen/APNNA SC accepting new patients
    Phoenix, Arizona, 85012, United States
  • Novartis Investigative Site accepting new patients
    Vancouver, British Columbia, V6H 3V4, Canada
  • Texas Children's Hospital SC-2 accepting new patients
    Houston, Texas, 77030, United States
  • Novartis Investigative Site accepting new patients
    Guadalajara, Jalisco, 44280, Mexico
  • Minnesota Epilepsy Group in progress, not accepting new patients
    Saint Paul, Minnesota, 55102-2383, United States
  • University of Chicago Medical Center accepting new patients
    Chicago, Illinois, 60637, United States
  • Atlantic Health Systems accepting new patients
    Morristown, New Jersey, 07962, United States
  • Connecticut Childrens Medical Center accepting new patients
    Hartford, Connecticut, 06106, United States
  • Novartis Investigative Site accepting new patients
    Samara, Samara region, 443095, Russian Federation
  • Novartis Investigative Site accepting new patients
    Voronezh, Voronezh region, 394024, Russian Federation
  • Novartis Investigative Site accepting new patients
    Moscow, 119991, Russian Federation
  • Novartis Investigative Site accepting new patients
    Moscow, 127412, Russian Federation
  • Novartis Investigative Site accepting new patients
    Okayama-city, Okayama, 700-8558, Japan
  • Novartis Investigative Site accepting new patients
    Osaka-city, Osaka, 534-0021, Japan
  • Novartis Investigative Site accepting new patients
    Suita-city, Osaka, 565-0871, Japan
  • Novartis Investigative Site accepting new patients
    Shizuoka-city, Shizuoka, 420-8688, Japan
  • Novartis Investigative Site accepting new patients
    Brussel, 1090, Belgium
  • Novartis Investigative Site accepting new patients
    Bruxelles, 1200, Belgium
  • Novartis Investigative Site accepting new patients
    Gent, 9000, Belgium
  • Novartis Investigative Site accepting new patients
    Leuven, 3000, Belgium
  • Novartis Investigative Site accepting new patients
    Seoul, 03080, Korea, Republic of
  • Novartis Investigative Site accepting new patients
    Seoul, 03722, Korea, Republic of
  • Novartis Investigative Site accepting new patients
    Seoul, 06351, Korea, Republic of
  • Novartis Investigative Site accepting new patients
    Amiens Cedex 1, 80054, France
  • Novartis Investigative Site accepting new patients
    Lille Cedex, 59037, France
  • Novartis Investigative Site accepting new patients
    Marseille Cedex 5, 13385, France
  • Novartis Investigative Site accepting new patients
    Madrid, 28009, Spain
  • Novartis Investigative Site accepting new patients
    Madrid, 28041, Spain
  • Novartis Investigative Site accepting new patients
    Warszawa, 04-730, Poland
  • Novartis Investigative Site accepting new patients
    Budapest, 1145, Hungary
  • Novartis Investigative Site accepting new patients
    Bologna, BO, 40139, Italy
  • Novartis Investigative Site accepting new patients
    Siena, SI, 53100, Italy
  • Novartis Investigative Site accepting new patients
    Taipei, 10002, Taiwan
  • Novartis Investigative Site accepting new patients
    Bangkok, 10700, Thailand
  • Novartis Investigative Site accepting new patients
    Randwick, New South Wales, 2130, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02962414
Phase
Phase 3
Lead Scientist
Rachel A. Kuperman
Study Type
Interventional
Last Updated
August 24, 2017
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