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.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-002977-37-BE (EUCTR) | 06/07/2017 | 04/04/2017 | Roll-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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 3 | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of | ||
| 2 | EUCTR2016-002977-37-ES (EUCTR) | 12/04/2017 | 10/03/2017 | Roll-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.A | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of | ||
| 3 | EUCTR2016-002977-37-HU (EUCTR) | 24/02/2017 | 18/01/2017 | Roll-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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 3 | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of | ||
| 4 | EUCTR2013-003795-13-BE (EUCTR) | 10/12/2014 | 17/11/2014 | Long-term monitoring of growth and development of pediatric patients previously treated with everolimus | Long-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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3;Phase 4 | United States;Canada;Poland;Belgium;Russian Federation | ||
| 5 | EUCTR2011-000860-90-IE (EUCTR) | 05/06/2014 | 10/04/2014 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | United 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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2011-000860-90-BE (EUCTR) | 17/09/2013 | 05/06/2013 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | United 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 | ||
| 7 | EUCTR2011-000860-90-DK (EUCTR) | 09/09/2013 | 09/09/2013 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | Taiwan;Greece;Spain;Ireland;Turkey;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of | ||
| 8 | EUCTR2011-000860-90-NL (EUCTR) | 30/07/2013 | 05/02/2013 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | United 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 | ||
| 9 | EUCTR2011-000860-90-HU (EUCTR) | 24/05/2013 | 30/05/2013 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 355 | Phase 3 | United 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 | ||
| 10 | EUCTR2012-005397-63-ES (EUCTR) | 19/04/2013 | 16/01/2014 | Expanded 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 | ,NULL | Not Recruiting | Female: yes Male: yes | Spain | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2010-019519-39-NL (EUCTR) | 14/03/2012 | 01/12/2011 | Efficacy 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 Neurology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 12 | EUCTR2010-022583-13-BE (EUCTR) | 01/06/2011 | 03/03/2011 | 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 | 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). | Trade Name: Votubia Product Name: everolimus Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Czech Republic;Hungary;Greece;Spain;Belgium;Germany;Italy | ||
| 13 | EUCTR2016-002977-37-PL (EUCTR) | 09/06/2017 | Roll-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 AG | NULL | NA | Female: yes Male: yes | 216 | Phase 3 | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of | |||
| 14 | EUCTR2013-003795-13-PL (EUCTR) | 20/01/2015 | Long-term monitoring of growth and development of pediatric patients previously treated with everolimus | Long-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 3 | United States;Canada;Belgium;Poland;Russian Federation |