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
NCT ID: NCT02962414
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
206 participants
INTERVENTIONAL
2017-06-08
2027-08-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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everolimus
everolimus, 2mg dispersible tablets
everolimus
everolimus, 2mg dispersible tablets
Interventions
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everolimus
everolimus, 2mg dispersible tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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Nedlands, Western Australia, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Vancouver, British Columbia, Canada
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Cali, Valle del Cauca Department, Colombia
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Amiens, , France
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Bron, , France
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Lille, , France
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Marseille, , France
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Strasbourg, , France
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Budapest, , Hungary
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Bari, BA, Italy
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Bologna, BO, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Siena, SI, Italy
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Suita, Osaka, Japan
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Shizuoka, Shizuoka, Japan
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Okayama, , Japan
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Osaka, , Japan
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Guadalajara, Jalisco, Mexico
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Warsaw, , Poland
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Samara, Samara Oblast, Russia
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Moscow, , Russia
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Moscow, , Russia
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Voronezh, , Russia
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Donostia / San Sebastian, Gipuzkoa, Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Seville, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Istanbul, Fatih, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Birmingham, West Midlands, United Kingdom
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Buckinghamshire, , United Kingdom
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Cambridge, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Sheffield, , United Kingdom
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York, , United Kingdom
Countries
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Other Identifiers
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2024-516746-19-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CRAD001M2X02B
Identifier Type: -
Identifier Source: org_study_id
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