158. 結節性硬化症
[臨床試験数:100,薬物数:62(DrugBank:16),標的遺伝子数:35,標的パスウェイ数:115

Searched query = "Tuberous sclerosis", "Tuberous sclerosis complex"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
42 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002977-37-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
2EUCTR2016-002977-37-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
3EUCTR2016-002977-37-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
4EUCTR2013-003795-13-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
5EUCTR2011-000860-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-000860-90-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
7EUCTR2011-000860-90-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
8EUCTR2011-000860-90-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
9EUCTR2011-000860-90-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
10EUCTR2011-000860-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-000860-90-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
12NCT01713946
(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
13EUCTR2012-005397-63-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
14EUCTR2011-000860-90-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
15EUCTR2011-000860-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01730209
(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
17NCT01954693
(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
18EUCTR2010-019519-39-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
19EUCTR2011-004854-25-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]
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
20EUCTR2010-022583-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-022583-13-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
22EUCTR2007-006997-27-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
23EUCTR2010-022583-13-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
24EUCTR2010-022583-13-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
25EUCTR2010-022583-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01289912
(ClinicalTrials.gov)
January 20112/2/2011Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC)Randomized Double-Blind Phase 2 Trial Of RAD001 For Neurocognition In Individuals With Tuberous Sclerosis ComplexTuberous Sclerosis ComplexDrug: RAD001;Drug: PlaceboMustafa SahinTuberous Sclerosis Alliance;Autism Speaks;Novartis Pharmaceuticals;Seizure Tracker LLCCompleted6 Years21 YearsAll52Phase 2United States
27EUCTR2007-006997-27-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
28EUCTR2008-002113-48-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
29EUCTR2007-006997-27-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
30EUCTR2007-006997-27-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).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): noBelgium;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2008-002113-48-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
32EUCTR2008-002113-48-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)
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
33EUCTR2007-006997-27-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
34NCT00790400
(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
35EUCTR2008-002113-48-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT00792766
(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
37NCT00457964
(ClinicalTrials.gov)
August 20056/4/2007RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAMRAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic LymphangioleiomyomatosisTuberous Sclerosis;LymphangioleiomyomatosisDrug: RAD001Children's Hospital Medical Center, CincinnatiNovartis PharmaceuticalsCompleted18 Years65 YearsBoth36Phase 1/Phase 2United States
38EUCTR2010-022583-13-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
39EUCTR2010-022583-13-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
40EUCTR2016-002977-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2013-003795-13-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
42EUCTR2008-002113-48-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