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Clinical Trials in the UK / NCT02962414
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 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2017-08-23
Last updated
2026-08-21

Condition(s) studied

Tuberous Sclerosis Complex

Investigational drug(s) / intervention(s)

everolimus

everolimus: everolimus, 2mg dispersible tablets

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

Eligibility

Sex
ALL
Min age
2 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (67)

FacilityCityRegionStatus
TGen APNNA Phoenix Arizona
David Geffen School of Medicine at UCLA Los Angeles California
UCSF Benioff Children s Hospital Oakland California
Rady Children s Hospital San Diego California
University of Colorado School of Medicine Aurora Colorado
Connecticut Childrens Medical Cntr Hartford Connecticut
University of Chicago Medical Center Chicago Illinois
Minnesota Epilepsy Group Saint Paul Minnesota
Atlantic Health Morristown MC Morristown New Jersey
Cinn Children Hosp Medical Center Cincinnati Ohio
Oregon Health Sciences University Portland Oregon
Childrens Hospital of Philadelphia Philadelphia Pennsylvania
Texas Scottish Rite Hos for Child Dallas Texas
Texas Childrens Hospital Houston Texas
Novartis Investigative Site Sydney New South Wales
Novartis Investigative Site Nedlands Western 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
Novartis Investigative Site Cali Valle del Cauca Department
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
Novartis Investigative Site Bologna BO
Novartis Investigative Site Pavia PV
Novartis Investigative Site Roma RM
Novartis Investigative Site Siena SI
Novartis Investigative Site Suita Osaka
Novartis Investigative Site Shizuoka Shizuoka
Novartis Investigative Site Okayama Japan
Novartis Investigative Site Osaka Japan
Novartis Investigative Site Guadalajara Jalisco
Novartis Investigative Site Warsaw Poland
Novartis Investigative Site Samara Samara Oblast

+ 27 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02962414 on ClinicalTrials.gov ↗ ← All trials in the UK