Multiple Sclerosis Clinical Trial
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
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
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.
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.
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There are 68 Locations for this study
Phoenix Arizona, 85012, United States
Los Angeles California, 90005, United States
Oakland California, 94609, United States
San Diego California, 92123, United States
Aurora Colorado, 80045, United States
Hartford Connecticut, 06106, United States
Chicago Illinois, 60637, United States
Saint Paul Minnesota, 55102, United States
Morristown New Jersey, 07962, United States
Cincinnati Ohio, 45229, United States
Portland Oregon, 97239, United States
Philadelphia Pennsylvania, 19104, United States
Dallas Texas, 75219, United States
Houston Texas, 77030, United States
Randwick New South Wales, 2130, Australia
Nedlands Western Australia, 6009, Australia
Jette Brussel, 1090, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Vancouver British Columbia, V6H 3, Canada
Cali Valle Del Cauca, 76001, Colombia
Amiens , 80054, France
Bron Cedex , 69677, France
Lille Cedex , 59037, France
Marseille Cedex 05 , 13885, France
Strasbourg Cedex , F 670, France
Budapest , 1145, Hungary
Bari BA, 70124, Italy
Bologna BO, 40139, Italy
Pavia PV, 27100, Italy
Roma RM, 00161, Italy
Siena SI, 53100, Italy
Okayama-city Okayama, 700-8, Japan
Suita Osaka, 565 0, Japan
Shizuoka-city Shizuoka, 420-8, Japan
Osaka , 534-0, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Guadalajara Jalisco, 44280, Mexico
Warszawa , 04 73, Poland
Samara Samara Region, 44309, Russian Federation
Voronezh Voronezh Region, 39402, Russian Federation
Moscow , 11999, Russian Federation
Moscow , 12741, Russian Federation
Sevilla Andalucia, 41013, Spain
Barcelona Catalunya, 08035, Spain
San Sebastian Pais Vasco, 20080, Spain
Madrid , 28009, Spain
Madrid , 28041, Spain
Valencia , 46026, Spain
Kaohsiung City , 83301, Taiwan
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Ankara , 06500, Turkey
Istanbul , 34093, Turkey
Edgbaston Birmingham, B15 2, United Kingdom
Cambridge Cambrigdeshire, CB2 0, United Kingdom
Buckinghamshire , SL9 0, United Kingdom
Liverpool , L12 2, United Kingdom
London , SW17 , United Kingdom
London , WC1N , United Kingdom
Sheffield , S10 2, United Kingdom
York , YO31 , United Kingdom
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