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


臨床試験数 : 112 薬物数 : 71 - (DrugBank : 19) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 118

  
19 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05252585
(ClinicalTrials.gov)
April 23, 202316/2/2022A Phase IV 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
2EUCTR2016-002977-37-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
3EUCTR2016-002977-37-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
4EUCTR2016-002977-37-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
5EUCTR2016-002977-37-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
6EUCTR2016-002977-37-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
7EUCTR2016-002977-37-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
8EUCTR2013-003795-13-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: 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: 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
9EUCTR2011-000860-90-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
10EUCTR2011-000860-90-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
11EUCTR2011-000860-90-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
12EUCTR2011-000860-90-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
13EUCTR2011-000860-90-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
14EUCTR2011-000860-90-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
15EUCTR2012-005397-63-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
16EUCTR2010-019519-39-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
17EUCTR2010-022583-13-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
18EUCTR2013-003795-13-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
19EUCTR2016-002977-37-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