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

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.

ClinicalTrials.gov Identifier: NCT02962414

Novartis Reference Number: CRAD001M2X02B

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Tuberous Sclerosis Complex
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
206 participants
Start date 
Apr 02, 2017
Completion date 
Aug 04, 2027
Gender 
All
Age(s)
2 Years - 65 Years (Child, Adult, Older Adult)

Interventions

Drug
everolimus
everolimus, 2mg dispersible tablets

Eligibility Criteria

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 Locations

United States
TGen/APNNA SC
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Phoenix, 85012
Arizona
United States
David Geffen School of Medicine at UCLA
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Los Angeles, 90005-1752
California
United States
UCSF Benioff Children s Hospital
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Oakland, 94609
California
United States
Rady Children s Hospital SC
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San Diego, 92123
California
United States
University of Colorado School of Medicine
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Aurora, 80045
Colorado
United States
Connecticut Childrens Medical Center
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Hartford, 06106
Connecticut
United States
University of Chicago Medical Center
-
Chicago, 60637
Illinois
United States
Minnesota Epilepsy Group
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Saint Paul, 55102
Minnesota
United States
Atlantic Health Systems
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Morristown, 07962
New Jersey
United States
Cincinnati Children s Hospital Medical Center SC-2
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Cincinnati, 45229-3039
Ohio
United States
Oregon Health and Science University
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Portland, 97239
Oregon
United States
Childrens Hospital of Philadelphia
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Philadelphia, 19104
Pennsylvania
United States
Texas Scottish Rite Hospital for Children SC
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Dallas, 75219
Texas
United States
Texas Children s Hospital SC-2
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Houston, 77030
Texas
United States
Australia
Novartis Investigative Site
-
Randwick, 2130
New South Wales
Australia
Novartis Investigative Site
-
Nedlands, 6009
Western Australia
Australia
Belgium
Novartis Investigative Site
-
Jette, 1090
Brussel
Belgium
Novartis Investigative Site
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Bruxelles, 1200
-
Belgium
Novartis Investigative Site
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Gent, 9000
-
Belgium
Novartis Investigative Site
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Leuven, 3000
-
Belgium
Canada
Novartis Investigative Site
-
Vancouver, V6H 3V4
British Columbia
Canada
Colombia
Novartis Investigative Site
-
Cali,
Valle Del Cauca
Colombia
France
Novartis Investigative Site
-
Amiens Cedex 1, 80054
-
France
Novartis Investigative Site
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Bron Cedex, 69677
-
France
Novartis Investigative Site
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Lille Cedex, 59037
-
France
Novartis Investigative Site
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Marseille Cedex 5, 13385
-
France
Novartis Investigative Site
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Strasbourg Cedex, F 67098
-
France
Hungary
Novartis Investigative Site
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Budapest, 1145
-
Hungary
Italy
Novartis Investigative Site
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Bari, 70124
BA
Italy
Novartis Investigative Site
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Bologna, 40139
BO
Italy
Novartis Investigative Site
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Pavia, 27100
PV
Italy
Novartis Investigative Site
-
Roma, 00161
RM
Italy
Novartis Investigative Site
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Siena, 53100
SI
Italy
Japan
Novartis Investigative Site
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Okayama-city, 700-8558
Okayama
Japan
Novartis Investigative Site
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Suita city, 565 0871
Osaka
Japan
Novartis Investigative Site
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Shizuoka-city, 420-8688
Shizuoka
Japan
Novartis Investigative Site
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Osaka, 534-0021
-
Japan
Korea, Republic of
Novartis Investigative Site
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Seoul, 03080
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 03722
-
Korea, Republic of
Novartis Investigative Site
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Seoul, 06351
-
Korea, Republic of
Mexico
Novartis Investigative Site
-
Guadalajara, 44280
Jalisco
Mexico
Poland
Novartis Investigative Site
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Warszawa, 04 730
-
Poland
Russian Federation
Novartis Investigative Site
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Samara, 443095
Samara Region
Russian Federation
Novartis Investigative Site
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Voronezh, 394024
Voronezh Region
Russian Federation
Novartis Investigative Site
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Moscow, 119991
-
Russian Federation
Novartis Investigative Site
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Moscow, 127412
-
Russian Federation
Spain
Novartis Investigative Site
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Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
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Barcelona, 08035
Catalunya
Spain
Novartis Investigative Site
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San Sebastian, 20080
Pais Vasco
Spain
Novartis Investigative Site
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Madrid, 28009
-
Spain
Novartis Investigative Site
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Madrid, 28041
-
Spain
Novartis Investigative Site
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Valencia, 46026
-
Spain
Taiwan
Novartis Investigative Site
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Kaohsiung City, 83301
-
Taiwan
Novartis Investigative Site
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Tainan, 70403
-
Taiwan
Novartis Investigative Site
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Taipei, 10002
-
Taiwan
Thailand
Novartis Investigative Site
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Bangkok, 10330
-
Thailand
Novartis Investigative Site
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Bangkok, 10400
-
Thailand
Novartis Investigative Site
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Bangkok, 10700
-
Thailand
Turkey
Novartis Investigative Site
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Ankara, 06500
-
Turkey
Novartis Investigative Site
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Istanbul, 34093
-
Turkey
United Kingdom
Novartis Investigative Site
-
Edgbaston, B15 2TH
Birmingham
United Kingdom
Novartis Investigative Site
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Cambridge, CB2 0QQ
Cambrigdeshire
United Kingdom
Novartis Investigative Site
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Buckinghamshire, SL9 0RJ
-
United Kingdom
Novartis Investigative Site
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Liverpool, L12 2AP
-
United Kingdom
Novartis Investigative Site
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London, SW17 0QT
-
United Kingdom
Novartis Investigative Site
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London, WC1N 3JH
-
United Kingdom
Novartis Investigative Site
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Sheffield, S10 2TH
-
United Kingdom
Novartis Investigative Site
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York, YO31 7EX
-
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]