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ACTIVE NOT RECRUITING
NCT02962414
PHASE3

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

2 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2017-06-08

Completion Date

2027-08-13

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

everolimus

everolimus, 2mg dispersible tablets

Locations (68)

TGen APNNA

Phoenix, Arizona, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

UCSF Benioff Children s Hospital

Oakland, California, United States

Rady Children s Hospital

San Diego, California, United States

University of Colorado School of Medicine

Aurora, Colorado, United States

Connecticut Childrens Medical Cntr

Hartford, Connecticut, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Minnesota Epilepsy Group

Saint Paul, Minnesota, United States

Atlantic Health Systems

Morristown, New Jersey, United States

Cinn Children Hosp Medical Center

Cincinnati, Ohio, United States

Oregon Health Sciences University

Portland, Oregon, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Texas Scottish Rite Hos for Child

Dallas, Texas, United States

Texas Childrens Hospital

Houston, Texas, United States

Novartis Investigative Site

Sydney, New South Wales, Australia

Novartis Investigative Site

Nedlands, Western Australia, Australia

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Amiens, France

Novartis Investigative Site

Bron, France

Novartis Investigative Site

Lille, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Strasbourg, France

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Bari, BA, Italy

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Pavia, PV, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Siena, SI, Italy

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Shizuoka, Shizuoka, Japan

Novartis Investigative Site

Okayama, Japan

Novartis Investigative Site

Osaka, Japan

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Novartis Investigative Site

Warsaw, Poland

Novartis Investigative Site

Samara, Samara Oblast, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Voronezh, Russia

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Novartis Investigative Site

Donostia / San Sebastian, Gipuzkoa, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Seville, Spain

Novartis Investigative Site

Valencia, Spain

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Tainan, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Bangkok, Thailand

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Ankara, Yenimahalle, Turkey (Türkiye)

Novartis Investigative Site

Birmingham, West Midlands, United Kingdom

Novartis Investigative Site

Buckinghamshire, United Kingdom

Novartis Investigative Site

Cambridge, United Kingdom

Novartis Investigative Site

Liverpool, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Sheffield, United Kingdom

Novartis Investigative Site

York, United Kingdom