158. 結節性硬化症 Tuberous sclerosis Clinical trials / Disease details


臨床試験数 : 108 薬物数 : 67 - (DrugBank : 17) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118

  
59 trials found
No.TrialIDDate_
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1NCT05252585
(ClinicalTrials.gov)
May 31, 202216/2/2022A Study of Safety and Efficacy of Everolimus in Taiwanese Patients With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma (TSC-AML)Phase IV, Prospective Single Arm Study of Safety and Efficacy of Votubia (Everolimus) in Taiwanese Adults With Tuberous Sclerosis Complex Who Have Renal AngiomyolipomaRenal AngiomyolipomaDrug: EverolimusNovartis PharmaceuticalsNULLNot yet recruiting20 Years65 YearsAll10Phase 4NULL
2ChiCTR2000039523
2020-12-012020-10-30Safety and efficacy of everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series studySafety and efficacy of Everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series study tuberous sclerosis complex;LD2D.2case series:everolimus;Department of Pharmacy, Peking University First HospitaNULLRecruiting0100Bothcase series:20;Phase 4China
3NCT02860494
(ClinicalTrials.gov)
December 20204/8/2016Topical Everolimus in Patients With Tuberous Sclerosis ComplexTopical Everolimus Versus Placebo for the Treatment of Facial Angiofibromas in Patients With Tuberous Sclerosis Complex. A Phase II/III, Multicentre, Randomized, Double-blind, Placebo-controlled Study of 3 Doses of Topical Everolimus.Facial AngiofibromasDrug: Everolimus;Drug: PlaceboHospices Civils de LyonNULLWithdrawnN/A2 YearsAll0Phase 2/Phase 3France
4EUCTR2016-002977-37-IT
(EUCTR)
17/07/201901/06/2021Roll-over study in patients with TSC and refractory seizures who arejudged by the Investigator to benefit from continued treatment witheverolimus after completion of study CRAD001M2304.An open-label, multi-center long-term safety roll-over study in patientswith tuberous sclerosis complex (TSC) and refractory seizures who arejudged by the Investigator to benefit from continued treatment witheverolimus after completion of study CRAD001M2304. - - Refractory seizures associated with tuberous sclerosis complex
MedDRA version: 21.0;Level: LLT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: -
Product Code: [-]
INN or Proposed INN: EVEROLIMUS
Other descriptive name: EVEROLIMUS
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
216Phase 3United States;Taiwan;Greece;Spain;Thailand;Korea, Democratic People's Republic of;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan
5NCT03525834
(ClinicalTrials.gov)
November 9, 20183/5/2018Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex.Phase IV, Single Arm Study of Safety and Efficacy of Everolimus in Chinese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma Not Requiring Immediate SurgeryRenal AngiomyolipomaDrug: EverolimusNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll40Phase 4China
6EUCTR2018-002531-18-FR
(EUCTR)
31/10/201811/07/2018Topical Everolimus versus placebo for the treatment of facial angiofibromas in patients with tuberous sclerosis complex. Topical Everolimus versus placebo for the treatment of facial angiofibromas in patients with tuberous sclerosis complex. A phase II/III, multicentre, randomized, double-blind, placebo-controlled study of 3 doses of topical Everolimus. EVEROST angiofibromas
MedDRA version: 20.0;Level: PT;Classification code 10002429;Term: Angiofibroma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: Everolimus
INN or Proposed INN: EVEROLIMUS
Other descriptive name: EVEROLIMUS
Product Name: Everolimus
INN or Proposed INN: Everolimus
Other descriptive name: EVEROLIMUS
Product Name: Everolimus
INN or Proposed INN: Everolimus
Other descriptive name: EVEROLIMUS
Hospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
146 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance
7EUCTR2016-002977-37-GB
(EUCTR)
25/08/201712/01/2017Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.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. Refractory seizures associated with tuberous sclerosis complex
MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
216 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of
8EUCTR2016-002977-37-BE
(EUCTR)
06/07/201704/04/2017Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.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. Refractory seizures associated with tuberous sclerosis complex
MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
216Phase 3United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of
9EUCTR2016-002977-37-ES
(EUCTR)
12/04/201710/03/2017Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.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. Refractory seizures associated with tuberous sclerosis complex
MedDRA version: 19.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Farmacéutica S.ANULLNot RecruitingFemale: yes
Male: yes
216Phase 3United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of
10NCT02962414
(ClinicalTrials.gov)
April 2, 20179/11/2016Roll-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 TreatmentAn 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.Tuberous Sclerosis ComplexDrug: everolimusNovartis PharmaceuticalsNULLActive, not recruiting2 Years65 YearsAll206Phase 3United States;Australia;Belgium;Canada;Colombia;France;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom
11EUCTR2016-002977-37-FR
(EUCTR)
24/03/201716/05/2017Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.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. Refractory seizures associated with tuberous sclerosis complex
MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
216 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of
12EUCTR2016-002977-37-HU
(EUCTR)
24/02/201718/01/2017Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.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. Refractory seizures associated with tuberous sclerosis complex
MedDRA version: 19.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
216Phase 3United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of
13ChiCTR-OPN-16008236
2016-06-012016-04-07TSC1/2 gene detection and Everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complexTSC1/2 gene detection and Everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complex renal angiomyolipoma10mg Everolimus:Everolimus 10mg QD for three months;5mg Everolimus:Everolimus 5mg QD for six months;General Hospital of PLANULLPending1860Both10mg Everolimus:50;5mg Everolimus:50;China
14EUCTR2013-003795-13-BE
(EUCTR)
10/12/201417/11/2014Long-term monitoring of growth and development of pediatric patients previously treated with everolimusLong-term follow-up study to monitor the growth and development of pediatric patients previously treated with everolimus in study CRAD001M2301 - EXIST-LT Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex (TSC)
MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3;Phase 4United States;Canada;Poland;Belgium;Russian Federation
15NCT02201212
(ClinicalTrials.gov)
September 201423/7/2014Everolimus for Cancer With TSC1 or TSC2 MutationA Phase II Trial of Everolimus for Cancer Patients With Inactivating Mutations in TSC1 or TSC2 or Activating MTOR MutationsTSC1;TSC2;Tuberous Sclerosis Complex;MTORDrug: EverolimusDana-Farber Cancer InstituteNovartis PharmaceuticalsCompleted18 YearsN/AAll30Phase 2United States
16EUCTR2011-000860-90-IE
(EUCTR)
05/06/201410/04/2014A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 17.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
355Phase 3United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
17NCT02061397
(ClinicalTrials.gov)
March 201423/1/2014Safety of Simvastatin in LAM and TSCThe Safety of Simvastatin (SOS) in Patients With Pulmonary Lymphangioleiomyomatosis (LAM) and With Tuberous Sclerosis Complex (TSC)Lymphangioleiomyomatosis;Tuberous Sclerosis ComplexDrug: Simvastatin;Drug: Sirolimus Oral Product;Drug: Everolimus Oral ProductUniversity of PennsylvaniaThe LAM FoundationCompleted18 YearsN/AFemale10Phase 1/Phase 2United States
18NCT02451696
(ClinicalTrials.gov)
January 20148/10/2014A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCDA Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCDEpilepsy;Tuberous Sclerosis Complex;Focal Cortical DysplasiaDrug: EverolimusNYU Langone HealthNULLCompleted2 Years40 YearsAll15Phase 2United States
19EUCTR2011-000860-90-BE
(EUCTR)
17/09/201305/06/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 17.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
355Phase 3United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
20EUCTR2011-000860-90-GR
(EUCTR)
12/09/201308/07/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 16.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
345Phase 3United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
21EUCTR2011-000860-90-DK
(EUCTR)
09/09/201309/09/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
355Phase 3Taiwan;Greece;Spain;Ireland;Turkey;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of
22JPRN-UMIN000011559
2013/09/0101/09/2013Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis 1.advanced renal cell carcinoma2.renal angiomyolipoma associated with tuberous sclerosis complexEverolimus 5mg/day.Department of Urology, Keio University School of MedicineNULLComplete: follow-up complete20years-old90years-oldMale and Female43Not selectedJapan
23EUCTR2011-000860-90-NL
(EUCTR)
30/07/201305/02/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 19.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
355Phase 3United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
24EUCTR2011-000860-90-DE
(EUCTR)
19/07/201325/03/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 19.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Everolimus 2mg dispersible tablet
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
355Phase 3United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of
25NCT01929642
(ClinicalTrials.gov)
July 20137/8/2013Rapalogues for Autism Phenotype in TSC: A Feasibility StudyRapalogues for Autism Phenotype in TSC: A Feasibility StudyTuberous Sclerosis Complex;Self-injury;AutismDrug: Sirolimus;Drug: EverolimusHugo W. Moser Research Institute at Kennedy Krieger, Inc.NULLCompleted2 Years30 YearsAll3Phase 2United States
26EUCTR2011-000860-90-GB
(EUCTR)
30/05/201303/06/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 19.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
355 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
27EUCTR2011-000860-90-HU
(EUCTR)
24/05/201330/05/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
355Phase 3United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
28NCT01713946
(ClinicalTrials.gov)
April 29, 20139/10/2012A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset SeizuresA Three-arm, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Two Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) Who Have Refractory Partial-onset SeizuresTuberous Sclerosis Complex-associated Refractory SeizuresDrug: RAD001;Drug: Placebo;Drug: Antiepileptic drug (1 to 3 only);Drug: open label RAD001 (only used for post-extension phase)Novartis PharmaceuticalsNULLCompleted2 Years65 YearsAll366Phase 3United States;Argentina;Australia;Belgium;Canada;Colombia;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Norway;Poland;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom;Sweden
29EUCTR2012-005397-63-ES
(EUCTR)
19/04/201316/01/2014Expanded access study of RAD001 in patient with angiomyolipoma associated with tuberous sclerosis complex (TSC)An open-label, multi-center, expanded access study of RAD001 in patients with angiomyolipoma associated with tuberous sclerosis complex (TSC) Angiomyolipoma associated with either Tuberous Sclerosis Complex (TSC)
MedDRA version: 16.1;Level: PT;Classification code 10051810;Term: Angiomyolipoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Farmacéutica, S.A,NULLNot RecruitingFemale: yes
Male: yes
Spain
30EUCTR2011-000860-90-IT
(EUCTR)
28/03/201304/02/2013A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 15.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
345Phase 3United States;Taiwan;Greece;Thailand;Spain;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
31EUCTR2011-000860-90-ES
(EUCTR)
14/02/201321/12/2012A study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizuresA three-arm, randomized, double-blind, placebo-controlled study of the efficacy and safety of two trough-ranges of everolimus as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who have refractory partial-onset seizures Refractory partial-onset seizures associated with tuberous sclerosis complex (TSC)
MedDRA version: 14.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
345Phase 3United Kingdom;Italy;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of;United States;Taiwan;Greece;Spain;Thailand;Ireland;Turkey;Russian Federation;Colombia
32NCT01730209
(ClinicalTrials.gov)
November 201226/10/2012Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis ComplexEfficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis ComplexTuberous Sclerosis Complex;TSC Related Cognitive Disability;TSC Related Autism;TSC Related Learning ProblemsDrug: Everolimus;Drug: PlaceboErasmus Medical CenterUtrecht UniversityRecruiting4 Years15 YearsBoth60Phase 2/Phase 3Netherlands
33NCT01954693
(ClinicalTrials.gov)
June 20125/9/2013A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous SclerosisTRON: A Randomised, Double Blind, Placebo-controlled Study of RAD001 (Everolimus) in the Treatment of Neurocognitive Problems in Tuberous SclerosisTuberous SclerosisDrug: Placebo;Drug: Everolimus (RAD001)Cardiff UniversityNovartisUnknown status16 Years60 YearsAll48Phase 2United Kingdom
34EUCTR2010-019519-39-NL
(EUCTR)
14/03/201201/12/2011Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with tuberous sclerosis complex (RAPIT-trial)Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial) - RAPIT Tuberous Sclerosis Complex;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]Trade Name: Votubia
Product Name: Everolimus
Product Code: L04AA18
INN or Proposed INN: Votubia
Other descriptive name: EVEROLIMUS
Erasmus MC - Department of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
35EUCTR2011-004854-25-GB
(EUCTR)
10/01/201222/11/2011TRON: A trial to examine the effectiveness of the study drug (Everolimus) in the treatment of cognitive problems experienced by patients with tuberous sclerosis.TRON: A randomised, double blind, placebo-controlled study of RAD001 (Everolimus) in the treatment of neurocognitive problems in tuberous sclerosis. - TRON (version 1.0) Tuberous Sclerosis Complex (TSC)
MedDRA version: 14.0;Level: PT;Classification code 10002649;Term: Anorexia nervosa;System Organ Class: 10037175 - Psychiatric disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Afinitor
Product Name: Everolimus
INN or Proposed INN: Everolimus
Other descriptive name: RAD001
Cardiff UniversityNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
36EUCTR2010-022583-13-IT
(EUCTR)
06/07/201127/04/2011An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA. - EFFECTS STUDYAn open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA. - EFFECTS STUDY Subependymal giant cell astrocytomas (SEGA)associated with Tuberous Sclerosis Complex (TSC)
MedDRA version: 13.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy
37EUCTR2010-022583-13-BE
(EUCTR)
01/06/201103/03/2011An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDYAn open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDY The study will evaluate the safety of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Hungary;Greece;Spain;Belgium;Germany;Italy
38EUCTR2007-006997-27-BE
(EUCTR)
01/06/201129/05/2009A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/AA randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/A This study will evaluate the antitumor activity of RAD001 versus placebo in patientswith subependymal giant cell astrocytomas (SEGA) associated with TuberousSclerosis Complex (TSC).Trade Name: Certican 1 mg tablets
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: everolimus
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
99Belgium;Netherlands;Germany;United Kingdom;Italy
39EUCTR2010-022583-13-CZ
(EUCTR)
01/06/201123/02/2011An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDYAn open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDY The study will evaluate the safety of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Phase 3France;Hungary;Czech Republic;Greece;Belgium;Spain;Germany;Italy
40EUCTR2010-022583-13-GR
(EUCTR)
18/04/201124/03/2011The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA.An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDY The study will evaluate the safety of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy
41EUCTR2010-022583-13-HU
(EUCTR)
31/03/201122/02/2011An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDYAn open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDY The study will evaluate the safety of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).
MedDRA version: 14.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy
42EUCTR2007-006997-27-NL
(EUCTR)
25/03/201003/12/2014Effectiveness and safety of RAD001 in patients of all ages with Subependymal Giant Cell Astrocytoma associated with Tuberous Sclerosis Complex (TSC)A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/A This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).
MedDRA version: 17.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: everolimus
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
99Canada;Poland;Belgium;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom
43EUCTR2008-002113-48-NL
(EUCTR)
16/03/201002/04/2009A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 9.1;Level: LLT;Classification code 10051810;Term: Angiomyolipoma
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
99France;Spain;Germany;Netherlands;Italy;United Kingdom
44EUCTR2007-006997-27-DE
(EUCTR)
12/03/201020/01/2010A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/AA randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/A This study will evaluate the antitumor activity of RAD001 versus placebo in patientswith subependymal giant cell astrocytomas (SEGA) associated with TuberousSclerosis Complex (TSC).Product Name: RAD001 1mg
Product Code: RAD001
INN or Proposed INN: everolimus
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
99Italy;Belgium;Netherlands;Germany;United Kingdom
45NCT01070316
(ClinicalTrials.gov)
January 201015/2/2010Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC)Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis ComplexEpilepsy;Tuberous Sclerosis ComplexDrug: EverolimusChildren's Hospital Medical Center, CincinnatiNovartisCompleted2 YearsN/AAll20Phase 1/Phase 2United States
46EUCTR2007-006997-27-GB
(EUCTR)
16/09/200906/07/2009A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/AA randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - N/A This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).Product Name: RAD001 round tablets
Product Code: RAD001
INN or Proposed INN: everolimus
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
99 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom;Italy;Germany;Netherlands;Belgium
47EUCTR2008-002113-48-IT
(EUCTR)
03/09/200907/09/2009A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - NDA randomized, double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - ND Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 12.0;Level: LLT;Classification code 10051810;Term: Angiomyolipoma
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: Everolimus
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
99France;Spain;Netherlands;Germany;United Kingdom;Italy
48EUCTR2008-002113-48-GB
(EUCTR)
06/08/200922/05/2009Efficacy and Safety of RAD001 in patients aged 18 and over with Angiomyolipoma associated with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - EXIST-2 Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 17.0;Level: PT;Classification code 10051810;Term: Angiomyolipoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Trade Name: Afinitor 5mg Tablets
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: Everolimus
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
118 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;Japan;United Kingdom
49NCT00789828
(ClinicalTrials.gov)
August 200912/11/2008Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)A Randomized, Double-blind, Placebo-controlled Study of Everolimus in the Treatment of Patients With Subependymal Giant Cell Astrocytomas (SEGA) Associated With Tuberous Sclerosis Complex (TSC)Tuberous Sclerosis;Subependymal Giant Cell AstrocytomaDrug: Everolimus;Drug: PlaceboNovartis PharmaceuticalsNULLCompletedN/AN/AAll117Phase 3United States;Australia;Belgium;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;United Kingdom
50EUCTR2007-006997-27-IT
(EUCTR)
27/07/200918/06/2009A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - NDA randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC) - ND This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).
MedDRA version: 12.0;Level: LLT;Classification code 10060971;Term: Astrocytoma malignant
Product Code: RAD001
INN or Proposed INN: Everolimus
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
99Belgium;Netherlands;Germany;United Kingdom;Italy
51NCT00790400
(ClinicalTrials.gov)
April 200910/11/2008Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A Randomized, Double-blind, Placebo-controlled Study of RAD0001 in the Treatment of Angiomyolipoma in Patients With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)Tuberous Sclerosis Complex (TSC);Lymphangioleiomyomatosis (LAM)Drug: Everolimus (RAD001);Drug: Everolimus PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll118Phase 3United States;Canada;France;Germany;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom
52EUCTR2008-002113-48-FR
(EUCTR)
18/03/200919/03/2009A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 9.1;Level: LLT;Classification code 10051810;Term: Angiomyolipoma
Product Name: RAD001
Product Code: RAD001
INN or Proposed INN: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
99Phase 3France;Spain;Netherlands;Germany;Italy;United Kingdom
53NCT00792766
(ClinicalTrials.gov)
December 200817/11/2008Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis (TSC) and Sporadic Lymphangioleiomyomatosis (LAM)Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;AngiolipomaDrug: everolimus (RAD001)Children's Hospital Medical Center, CincinnatiNovartisCompleted18 Years65 YearsBoth20Phase 1/Phase 2United States
54NCT00411619
(ClinicalTrials.gov)
January 200712/12/2006Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis ComplexEverolimus (RAD001)Therapy of Giant Cell Astrocytomas in Patients With Tuberous Sclerosis ComplexTuberous Sclerosis;Subependymal Giant Cell AstrocytomaDrug: EverolimusChildren's Hospital Medical Center, CincinnatiNovartisCompleted3 YearsN/AAll28Phase 1/Phase 2United States
55EUCTR2010-022583-13-FR
(EUCTR)
01/03/2011An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDYAn open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDY The study will evaluate the safety of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Afinitor
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Afinitor
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
250Phase 3France;Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy
56EUCTR2010-022583-13-DE
(EUCTR)
23/12/2010An open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDYAn open-label, multi-center, expanded access study of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with tuberous sclerosis complex (TSC). The EFFECTS STUDY: Everolimus For Fast Expanded aCcess in TSC SEGA - EFFECTS STUDY The study will evaluate the safety of RAD001 in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).Product Name: RAD001 2,5 mg
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy
57EUCTR2016-002977-37-PL
(EUCTR)
09/06/2017Roll-over study in patients with TSC and refractory seizures who are judged by the Investigator to benefit from continued treatment with everolimus after completion of study CRAD001M2304.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. Refractory seizures associated with tuberous sclerosis complex
MedDRA version: 20.0;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: Everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma AGNULLNAFemale: yes
Male: yes
216Phase 3United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of
58EUCTR2013-003795-13-PL
(EUCTR)
20/01/2015Long-term monitoring of growth and development of pediatric patients previously treated with everolimusLong-term follow-up study to monitor the growth and development of pediatric patients previously treated with everolimus in study CRAD001M2301 - EXIST-LT Subependymal Giant Cell Astrocytoma (SEGA) associated with Tuberous Sclerosis Complex (TSC)
MedDRA version: 17.1;Level: PT;Classification code 10045138;Term: Tuberous sclerosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Trade Name: Votubia
Product Name: everolimus
Product Code: RAD001
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
INN or Proposed INN: everolimus
Other descriptive name: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
48Phase 3United States;Canada;Belgium;Poland;Russian Federation
59EUCTR2008-002113-48-DE
(EUCTR)
12/02/2009Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)A randomized double-blind, placebo-controlled study of RAD001 in the treatment of Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) - EXIST-2 Angiomyolipoma in patients with either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
MedDRA version: 16.1;Level: PT;Classification code 10051810;Term: Angiomyolipoma;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps);Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Afinitor
Product Name: RAD001 5mg
Product Code: RAD001
INN or Proposed INN: EVEROLIMUS
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
118Phase 3France;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan