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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

June 8, 2017

Primary Completion Date

August 4, 2027

Study Completion Date

August 13, 2027

Conditions
Tuberous Sclerosis Complex
Interventions
DRUG

everolimus

everolimus, 2mg dispersible tablets

Trial Locations (68)

1090

Novartis Investigative Site, Brussels

1145

Novartis Investigative Site, Budapest

1200

Novartis Investigative Site, Brussels

2031

Novartis Investigative Site, Randwick

3000

Novartis Investigative Site, Leuven

6009

Novartis Investigative Site, Nedlands

9000

Novartis Investigative Site, Ghent

10002

Novartis Investigative Site, Taipei

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

13885

Novartis Investigative Site, Marseille

19104

Childrens Hospital of Philadelphia, Philadelphia

20080

Novartis Investigative Site, Donostia / San Sebastian

27100

Novartis Investigative Site, Pavia

28009

Novartis Investigative Site, Madrid

28041

Novartis Investigative Site, Madrid

34093

Novartis Investigative Site, Istanbul

40139

Novartis Investigative Site, Bologna

41013

Novartis Investigative Site, Seville

44280

Novartis Investigative Site, Guadalajara

46026

Novartis Investigative Site, Valencia

53100

Novartis Investigative Site, Siena

55102

Minnesota Epilepsy Group, Saint Paul

59037

Novartis Investigative Site, Lille

60637

University of Chicago Medical Center, Chicago

67000

Novartis Investigative Site, Strasbourg

69677

Novartis Investigative Site, Bron

70124

Novartis Investigative Site, Bari

70403

Novartis Investigative Site, Tainan City

75219

Texas Scottish Rite Hos for Child, Dallas

77030

Texas Childrens Hospital, Houston

80045

University of Colorado School of Medicine, Aurora

80054

Novartis Investigative Site, Amiens

83301

Novartis Investigative Site, Kaohsiung City

85012

TGen APNNA, Phoenix

92123

Rady Children s Hospital, San Diego

94609

UCSF Benioff Children s Hospital, Oakland

97239

Oregon Health Sciences University, Portland

119991

Novartis Investigative Site, Moscow

127412

Novartis Investigative Site, Moscow

394024

Novartis Investigative Site, Voronezh

443095

Novartis Investigative Site, Samara

760012

Novartis Investigative Site, Santiago de Cali

90005-1752

David Geffen School of Medicine at UCLA, Los Angeles

06106

Connecticut Childrens Medical Cntr, Hartford

07962

Atlantic Health Systems, Morristown

45229-3039

Cinn Children Hosp Medical Center, Cincinnati

V6H 3V4

Novartis Investigative Site, Vancouver

00161

Novartis Investigative Site, Roma

700-8558

Novartis Investigative Site, Okayama

565 0871

Novartis Investigative Site, Suita

420-8688

Novartis Investigative Site, Shizuoka

534-0021

Novartis Investigative Site, Osaka

04 730

Novartis Investigative Site, Warsaw

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

06500

Novartis Investigative Site, Ankara

B15 2TH

Novartis Investigative Site, Birmingham

SL9 0RJ

Novartis Investigative Site, Buckinghamshire

CB2 0QQ

Novartis Investigative Site, Cambridge

L12 2AP

Novartis Investigative Site, Liverpool

SW17 0QT

Novartis Investigative Site, London

WC1N 3JH

Novartis Investigative Site, London

S10 2TH

Novartis Investigative Site, Sheffield

YO31 7EX

Novartis Investigative Site, York

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY