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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02962414
Other study ID # CRAD001M2X02B
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 8, 2017
Est. completion date August 13, 2027

Study information

Verified date May 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 206
Est. completion date August 13, 2027
Est. primary completion date August 4, 2027
Accepts healthy volunteers No
Gender All
Age group 2 Years to 65 Years
Eligibility 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.

Study Design


Intervention

Drug:
everolimus
everolimus, 2mg dispersible tablets

Locations

Country Name City State
Australia Novartis Investigative Site Nedlands Western Australia
Australia Novartis Investigative Site Randwick New South Wales
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Gent
Belgium Novartis Investigative Site Jette Brussel
Belgium Novartis Investigative Site Leuven
Canada Novartis Investigative Site Vancouver British Columbia
Colombia Novartis Investigative Site Cali Valle Del Cauca
France Novartis Investigative Site Amiens
France Novartis Investigative Site Bron Cedex
France Novartis Investigative Site Lille Cedex
France Novartis Investigative Site Marseille Cedex 05
France Novartis Investigative Site Strasbourg
Hungary Novartis Investigative Site Budapest
Italy 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
Japan Novartis Investigative Site Okayama-city Okayama
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Shizuoka-city Shizuoka
Japan Novartis Investigative Site Suita Osaka
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Mexico Novartis Investigative Site Guadalajara Jalisco
Poland Novartis Investigative Site Warszawa
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Samara Samara Region
Russian Federation Novartis Investigative Site Voronezh Voronezh Region
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site San Sebastian Pais Vasco
Spain Novartis Investigative Site Sevilla Andalucia
Spain Novartis Investigative Site Valencia
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Tainan
Taiwan Novartis Investigative Site Taipei
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Thailand Novartis Investigative Site Bangkok
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Istanbul
United Kingdom Novartis Investigative Site Buckinghamshire
United Kingdom Novartis Investigative Site Cambridge Cambrigdeshire
United Kingdom Novartis Investigative Site Edgbaston Birmingham
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 States Novartis Investigative Site Aurora Colorado
United States Novartis Investigative Site Chicago Illinois
United States Novartis Investigative Site Cincinnati Ohio
United States Novartis Investigative Site Dallas Texas
United States Novartis Investigative Site Hartford Connecticut
United States Novartis Investigative Site Houston Texas
United States Novartis Investigative Site Los Angeles California
United States Novartis Investigative Site Morristown New Jersey
United States Novartis Investigative Site Oakland California
United States Novartis Investigative Site Philadelphia Pennsylvania
United States Novartis Investigative Site Phoenix Arizona
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site Saint Paul Minnesota
United States Novartis Investigative Site San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Colombia,  France,  Hungary,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Russian Federation,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurances of adverse events and serious adverse events The patients will be followed continuously for tolerability (i.e adverse events, serious adverse events) Day 1 up to approximately 10 years
Secondary Percentage of patients with clinical benefit At every quarterly visit (every 12 weeks ± 2 weeks), the Investigator is required to confirm that the patients continue to have clinical benefit as per Investigator's assessment. Day 1 up to approximately 10 years, assessed every 12 weeks,
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