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
| 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 | NCT05252585 (ClinicalTrials.gov) | May 31, 2022 | 16/2/2022 | A 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 Angiomyolipoma | Renal Angiomyolipoma | Drug: Everolimus | Novartis Pharmaceuticals | NULL | Not yet recruiting | 20 Years | 65 Years | All | 10 | Phase 4 | NULL |
| 2 | ChiCTR2000039523 | 2020-12-01 | 2020-10-30 | Safety and efficacy of everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series study | Safety and efficacy of Everolimus in patients with renal angiomyolipoma associated with tuberous sclerosis: a case series study | tuberous sclerosis complex;LD2D.2 | case series:everolimus; | Department of Pharmacy, Peking University First Hospita | NULL | Recruiting | 0 | 100 | Both | case series:20; | Phase 4 | China |
| 3 | NCT02860494 (ClinicalTrials.gov) | December 2020 | 4/8/2016 | Topical Everolimus 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. | Facial Angiofibromas | Drug: Everolimus;Drug: Placebo | Hospices Civils de Lyon | NULL | Withdrawn | N/A | 2 Years | All | 0 | Phase 2/Phase 3 | France |
| 4 | EUCTR2016-002977-37-IT (EUCTR) | 17/07/2019 | 01/06/2021 | Roll-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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 216 | Phase 3 | United 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 | ||
| 5 | NCT03525834 (ClinicalTrials.gov) | November 9, 2018 | 3/5/2018 | Safety 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 Surgery | Renal Angiomyolipoma | Drug: Everolimus | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 40 | Phase 4 | China |
| 6 | EUCTR2018-002531-18-FR (EUCTR) | 31/10/2018 | 11/07/2018 | Topical 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 Lyon | NULL | Authorised-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): no | France | ||
| 7 | EUCTR2016-002977-37-GB (EUCTR) | 25/08/2017 | 12/01/2017 | 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: 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | NCT02962414 (ClinicalTrials.gov) | April 2, 2017 | 9/11/2016 | Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment | 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. | Tuberous Sclerosis Complex | Drug: everolimus | Novartis Pharmaceuticals | NULL | Active, not recruiting | 2 Years | 65 Years | All | 206 | Phase 3 | United States;Australia;Belgium;Canada;Colombia;France;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Taiwan;Thailand;Turkey;United Kingdom |
| 11 | EUCTR2016-002977-37-FR (EUCTR) | 24/03/2017 | 16/05/2017 | 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 | Not 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): no | United States;Taiwan;Greece;Spain;Thailand;Turkey;Russian Federation;Colombia;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Japan;Korea, Republic of | ||
| 12 | 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 | ||
| 13 | ChiCTR-OPN-16008236 | 2016-06-01 | 2016-04-07 | TSC1/2 gene detection and Everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complex | TSC1/2 gene detection and Everolimus treatment for renal angiomyolipoma associated with tuberous sclerosis complex | renal angiomyolipoma | 10mg Everolimus:Everolimus 10mg QD for three months;5mg Everolimus:Everolimus 5mg QD for six months; | General Hospital of PLA | NULL | Pending | 18 | 60 | Both | 10mg Everolimus:50;5mg Everolimus:50; | China | |
| 14 | 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 | ||
| 15 | NCT02201212 (ClinicalTrials.gov) | September 2014 | 23/7/2014 | Everolimus for Cancer With TSC1 or TSC2 Mutation | A Phase II Trial of Everolimus for Cancer Patients With Inactivating Mutations in TSC1 or TSC2 or Activating MTOR Mutations | TSC1;TSC2;Tuberous Sclerosis Complex;MTOR | Drug: Everolimus | Dana-Farber Cancer Institute | Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 16 | 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 | ||
| 17 | NCT02061397 (ClinicalTrials.gov) | March 2014 | 23/1/2014 | Safety of Simvastatin in LAM and TSC | The Safety of Simvastatin (SOS) in Patients With Pulmonary Lymphangioleiomyomatosis (LAM) and With Tuberous Sclerosis Complex (TSC) | Lymphangioleiomyomatosis;Tuberous Sclerosis Complex | Drug: Simvastatin;Drug: Sirolimus Oral Product;Drug: Everolimus Oral Product | University of Pennsylvania | The LAM Foundation | Completed | 18 Years | N/A | Female | 10 | Phase 1/Phase 2 | United States |
| 18 | NCT02451696 (ClinicalTrials.gov) | January 2014 | 8/10/2014 | A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD | A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD | Epilepsy;Tuberous Sclerosis Complex;Focal Cortical Dysplasia | Drug: Everolimus | NYU Langone Health | NULL | Completed | 2 Years | 40 Years | All | 15 | Phase 2 | United States |
| 19 | 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 | ||
| 20 | EUCTR2011-000860-90-GR (EUCTR) | 12/09/2013 | 08/07/2013 | 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: 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 345 | 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 | ||
| 21 | 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 | ||
| 22 | JPRN-UMIN000011559 | 2013/09/01 | 01/09/2013 | Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosis | 1.advanced renal cell carcinoma2.renal angiomyolipoma associated with tuberous sclerosis complex | Everolimus 5mg/day. | Department of Urology, Keio University School of Medicine | NULL | Complete: follow-up complete | 20years-old | 90years-old | Male and Female | 43 | Not selected | Japan | |
| 23 | 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 | ||
| 24 | EUCTR2011-000860-90-DE (EUCTR) | 19/07/2013 | 25/03/2013 | 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: 19.1;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 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;Netherlands;Germany;Japan;Korea, Republic of | ||
| 25 | NCT01929642 (ClinicalTrials.gov) | July 2013 | 7/8/2013 | Rapalogues for Autism Phenotype in TSC: A Feasibility Study | Rapalogues for Autism Phenotype in TSC: A Feasibility Study | Tuberous Sclerosis Complex;Self-injury;Autism | Drug: Sirolimus;Drug: Everolimus | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | NULL | Completed | 2 Years | 30 Years | All | 3 | Phase 2 | United States |
| 26 | EUCTR2011-000860-90-GB (EUCTR) | 30/05/2013 | 03/06/2013 | 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: 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United 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 | ||
| 27 | 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 | ||
| 28 | NCT01713946 (ClinicalTrials.gov) | April 29, 2013 | 9/10/2012 | A 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 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 | Tuberous Sclerosis Complex-associated Refractory Seizures | Drug: RAD001;Drug: Placebo;Drug: Antiepileptic drug (1 to 3 only);Drug: open label RAD001 (only used for post-extension phase) | Novartis Pharmaceuticals | NULL | Completed | 2 Years | 65 Years | All | 366 | Phase 3 | United 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 |
| 29 | 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 | ||||
| 30 | EUCTR2011-000860-90-IT (EUCTR) | 28/03/2013 | 04/02/2013 | 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: 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 345 | 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 | ||
| 31 | EUCTR2011-000860-90-ES (EUCTR) | 14/02/2013 | 21/12/2012 | 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 345 | Phase 3 | United 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 | ||
| 32 | NCT01730209 (ClinicalTrials.gov) | November 2012 | 26/10/2012 | Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex | Efficacy of RAD001/Everolimus in Autism and NeuroPsychological Deficits in Children With Tuberous Sclerosis Complex | Tuberous Sclerosis Complex;TSC Related Cognitive Disability;TSC Related Autism;TSC Related Learning Problems | Drug: Everolimus;Drug: Placebo | Erasmus Medical Center | Utrecht University | Recruiting | 4 Years | 15 Years | Both | 60 | Phase 2/Phase 3 | Netherlands |
| 33 | NCT01954693 (ClinicalTrials.gov) | June 2012 | 5/9/2013 | A Study of Everolimus in the Treatment of Neurocognitive Problems in Tuberous Sclerosis | TRON: A Randomised, Double Blind, Placebo-controlled Study of RAD001 (Everolimus) in the Treatment of Neurocognitive Problems in Tuberous Sclerosis | Tuberous Sclerosis | Drug: Placebo;Drug: Everolimus (RAD001) | Cardiff University | Novartis | Unknown status | 16 Years | 60 Years | All | 48 | Phase 2 | United Kingdom |
| 34 | 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 | ||||
| 35 | EUCTR2011-004854-25-GB (EUCTR) | 10/01/2012 | 22/11/2011 | TRON: 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 University | NULL | Not 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): no | United Kingdom | ||
| 36 | EUCTR2010-022583-13-IT (EUCTR) | 06/07/2011 | 27/04/2011 | 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 | 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy | |||
| 37 | EUCTR2010-022583-13-CZ (EUCTR) | 01/06/2011 | 23/02/2011 | 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). | 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 | France;Hungary;Czech Republic;Greece;Belgium;Spain;Germany;Italy | ||
| 38 | EUCTR2007-006997-27-BE (EUCTR) | 01/06/2011 | 29/05/2009 | 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 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 99 | Belgium;Netherlands;Germany;United Kingdom;Italy | |||
| 39 | 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 | ||
| 40 | EUCTR2010-022583-13-GR (EUCTR) | 18/04/2011 | 24/03/2011 | The 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy | |||
| 41 | EUCTR2010-022583-13-HU (EUCTR) | 31/03/2011 | 22/02/2011 | 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). 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy | |||
| 42 | EUCTR2007-006997-27-NL (EUCTR) | 25/03/2010 | 03/12/2014 | Effectiveness 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 99 | Canada;Poland;Belgium;Australia;Russian Federation;Germany;Netherlands;Italy;United Kingdom | |||
| 43 | EUCTR2008-002113-48-NL (EUCTR) | 16/03/2010 | 02/04/2009 | 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) | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 99 | France;Spain;Germany;Netherlands;Italy;United Kingdom | |||
| 44 | EUCTR2007-006997-27-DE (EUCTR) | 12/03/2010 | 20/01/2010 | 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 | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 99 | Italy;Belgium;Netherlands;Germany;United Kingdom | |||
| 45 | NCT01070316 (ClinicalTrials.gov) | January 2010 | 15/2/2010 | Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC) | Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex | Epilepsy;Tuberous Sclerosis Complex | Drug: Everolimus | Children's Hospital Medical Center, Cincinnati | Novartis | Completed | 2 Years | N/A | All | 20 | Phase 1/Phase 2 | United States |
| 46 | EUCTR2007-006997-27-GB (EUCTR) | 16/09/2009 | 06/07/2009 | 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 | 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). | Product Name: RAD001 round tablets Product Code: RAD001 INN or Proposed INN: everolimus | Novartis Pharma Services AG | NULL | Not 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): no | United Kingdom;Italy;Germany;Netherlands;Belgium | ||
| 47 | EUCTR2008-002113-48-IT (EUCTR) | 03/09/2009 | 07/09/2009 | 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) - ND | 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) - 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 99 | France;Spain;Netherlands;Germany;United Kingdom;Italy | |||
| 48 | EUCTR2008-002113-48-GB (EUCTR) | 06/08/2009 | 22/05/2009 | Efficacy 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 AG | NULL | Not 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): no | France;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;Japan;United Kingdom | ||
| 49 | NCT00789828 (ClinicalTrials.gov) | August 2009 | 12/11/2008 | Efficacy 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 Astrocytoma | Drug: Everolimus;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 117 | Phase 3 | United States;Australia;Belgium;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;United Kingdom |
| 50 | EUCTR2007-006997-27-IT (EUCTR) | 27/07/2009 | 18/06/2009 | 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) - ND | 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) - 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 99 | Belgium;Netherlands;Germany;United Kingdom;Italy | |||
| 51 | NCT00790400 (ClinicalTrials.gov) | April 2009 | 10/11/2008 | Efficacy 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 Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 118 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 52 | EUCTR2008-002113-48-FR (EUCTR) | 18/03/2009 | 19/03/2009 | 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) | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 99 | Phase 3 | France;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 53 | NCT00792766 (ClinicalTrials.gov) | December 2008 | 17/11/2008 | Long 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 Lymphangioleiomyomatosis | Tuberous Sclerosis;Angiolipoma | Drug: everolimus (RAD001) | Children's Hospital Medical Center, Cincinnati | Novartis | Completed | 18 Years | 65 Years | Both | 20 | Phase 1/Phase 2 | United States |
| 54 | NCT00411619 (ClinicalTrials.gov) | January 2007 | 12/12/2006 | Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex | Everolimus (RAD001)Therapy of Giant Cell Astrocytomas in Patients With Tuberous Sclerosis Complex | Tuberous Sclerosis;Subependymal Giant Cell Astrocytoma | Drug: Everolimus | Children's Hospital Medical Center, Cincinnati | Novartis | Completed | 3 Years | N/A | All | 28 | Phase 1/Phase 2 | United States |
| 55 | EUCTR2008-002113-48-DE (EUCTR) | 12/02/2009 | Efficacy 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 118 | Phase 3 | France;United States;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Japan | |||
| 56 | EUCTR2010-022583-13-FR (EUCTR) | 01/03/2011 | 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). | 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 AG | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | France;Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy | |||
| 57 | 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 | |||
| 58 | 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 | |||
| 59 | EUCTR2010-022583-13-DE (EUCTR) | 23/12/2010 | 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). | Product Name: RAD001 2,5 mg Product Code: RAD001 INN or Proposed INN: everolimus Other descriptive name: EVEROLIMUS | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Hungary;Greece;Belgium;Spain;Germany;Italy |