Everolimus (DrugBank: Everolimus)
9 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 34 | 神経線維腫症 | 7 |
| 67 | 多発性嚢胞腎 | 6 |
| 89 | リンパ脈管筋腫症 | 11 |
| 96 | クローン病 | 1 |
| 137 | 限局性皮質異形成 | 2 |
| 157 | スタージ・ウェーバー症候群 | 1 |
| 158 | 結節性硬化症 | 54 |
| 228 | 閉塞性細気管支炎 | 3 |
| 277 | リンパ管腫症／ゴーハム病 | 1 |
| 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 | NCT01345136 (ClinicalTrials.gov) | July 1, 2015 | 21/4/2011 | Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma | A Single Arm, Monocenter Phase II Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis Type 2 - Related Vestibular Schwannoma | Neurofibromatosis Type 2;Neuroma, Acoustic | Drug: RAD001, everolimus | Jonsson Comprehensive Cancer Center | Novartis Pharmaceuticals | Active, not recruiting | 16 Years | 65 Years | All | 4 | Phase 2 | United States |
| 2 | NCT02332902 (ClinicalTrials.gov) | February 2015 | 12/12/2014 | Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1 CRAD001CUS232T | Everolimus for Treatment of Disfiguring Cutaneous Lesions in Neurofibromatosis1- CRAD001CUS232T | Neurofibromatosis 1 | Drug: Everolimus | The University of Texas Health Science Center, Houston | Texas Neurofibromatosis Foundation | Completed | 18 Years | N/A | All | 24 | Phase 2 | United States |
| 3 | NCT01661283 (ClinicalTrials.gov) | September 2012 | 7/8/2012 | SARC016: Study of Everolimus With Bevacizumab to Treat Refractory Malignant Peripheral Nerve Sheath Tumors | Phase 2 Study of the mTOR Inhibitor Everolimus in Combination With Bevacizumab in Patients With Sporadic and Neurofibromatosis Type 1 (NF1) Related Refractory Malignant Peripheral Nerve Sheath Tumors | Malignant Peripheral Nerve Sheath Tumors;MPNST;Sarcoma | Drug: everolimus;Drug: bevacizumab | Sarcoma Alliance for Research through Collaboration | Novartis Pharmaceuticals;Genentech, Inc.;United States Department of Defense | Completed | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 4 | NCT01365468 (ClinicalTrials.gov) | April 2012 | 27/5/2011 | Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1) | A Phase II Study of RAD001 in the Treatment of Patients With Plexiform Neurofibromas (PN) Associated With Neurofibromatosis Type 1 (NF1) | Plexiform Neurofibroma Associated With Neurofibromatosis Type 1 | Drug: Everolimus (RAD001) | Novartis Pharmaceuticals | NULL | Terminated | 6 Years | N/A | All | 9 | Phase 2 | Israel |
| 5 | NCT01419639 (ClinicalTrials.gov) | October 2011 | 17/8/2011 | Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2 | Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2 | Neurofibromatosis Type II | Drug: Everolimus (RAD001) , Afinitor® | New York University School of Medicine | Novartis Pharmaceuticals;The Children's Tumor Foundation | Completed | 3 Years | N/A | All | 10 | Phase 2 | United States |
| 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 | NCT01412892 (ClinicalTrials.gov) | April 2011 | 8/8/2011 | Use of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas | A Single Arm, Multicenter Phase II a Trial of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas That Cannot be Removed by Surgery | Neurofibromatosis Type 1;Plexiform Neurofibroma;Neurofibromatoses | Drug: RAD001: Everolimus | Assistance Publique - Hôpitaux de Paris | Novartis | Completed | 18 Years | 60 Years | Both | 30 | Phase 2 | France |
| 7 | EUCTR2016-001563-36-Outside-EU/EEA (EUCTR) | 12/05/2016 | Efficacy and Safety of RAD001 in Treating Plexiform Neurofibromas (PN) Associated With Neurofibromatosis (NF1) | A Phase II Study of RAD001 in the Treatment of Patients With Plexiform Neurofibromas (PN) Associated With Neurofibromatosis Type 1 (NF1) | Plexiform Neurofibroma Associated With Neurofibromatosis Type 1;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Votubia Product Name: Everolimus Product Code: RAD001 | Novartis Pharmaceuticals | NULL | NA | Female: yes Male: yes | 26 | Phase 4 | Israel |
| 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 | NCT02134899 (ClinicalTrials.gov) | October 14, 2014 | 28/4/2014 | The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients | An Open-labelled Multicenter Randomized Study on the Efficacy of Everolimus in Reducing Total Native Kidney Volume in Kidney Transplanted Patients With Autosomal Dominant Polycystic Kidney Disease | Autosomal Dominant Polycystic Kidney Disease | Drug: Everolimus;Drug: Calcineurin inhibitors maintenance | Assistance Publique - Hôpitaux de Paris | Novartis | Completed | 18 Years | 75 Years | All | 3 | Phase 3 | France |
| 2 | NCT01009957 (ClinicalTrials.gov) | June 2008 | 6/11/2009 | Everolimus on CKD Progression in ADPKD Patients | Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients | Polycystic Kidney Diseases | Drug: Everolimus | A. Manzoni Hospital | NULL | Terminated | 18 Years | N/A | Both | 71 | Phase 2;Phase 3 | Italy |
| 3 | EUCTR2006-001485-16-FR (EUCTR) | 20/08/2007 | 23/07/2007 | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | polycystic kidney disease MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease | Product Name: Certican Product Code: RAD001 INN or Proposed INN: Everolimus | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Austria;Germany | |||
| 4 | EUCTR2006-001485-16-AT (EUCTR) | 15/12/2006 | 16/11/2006 | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | polycystic kidney disease MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease | Product Name: Certican Tabletten Product Code: RAD001 INN or Proposed INN: Everolimus | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Austria;Germany | |||
| 5 | NCT00414440 (ClinicalTrials.gov) | December 2006 | 20/12/2006 | Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease in Patients With Autosomal Dominant Polycystic Kidney Disease | A Multicenter, Randomized, Placebo-controlled, Double-blind Study on the Efficacy, Safety and Tolerability of Everolimus in Preventing End-stage Renal Disease (ESRD) in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Autosomal Dominant Polycystic Kidney Disease | Drug: Placebo;Drug: Everolimus | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | All | 431 | Phase 4 | Austria;France;Germany |
| 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 | EUCTR2006-001485-16-DE (EUCTR) | 25/10/2006 | 19/01/2007 | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | A multicenter, randomized, placebo-controlled, double-blind study on the efficacy, safety and tolerability of Certican® in preventing end-stage renal disease (ESRD) in patients with autosomal dominant polycystic kidney disease (ADPKD) - ADPKD | polycystic kidney disease MedDRA version: 8.1;Level: LLT;Classification code 10011771;Term: Cystic kidney disease | Product Name: Certican Tabletten Product Code: RAD001 INN or Proposed INN: Everolimus | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Austria;Germany |
| 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 | NCT02432560 (ClinicalTrials.gov) | March 2015 | 4/3/2015 | Safety and Durability of Sirolimus for Treatment of LAM | Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS) | Lymphangioleiomyomatosis | Drug: Sirolimus;Drug: Everolimus | University of Cincinnati | Rare Diseases Clinical Research Network;National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);The LAM Foundation | Active, not recruiting | 18 Years | N/A | Female | 600 | United States | |
| 2 | 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 |
| 3 | EUCTR2010-019825-32-IT (EUCTR) | 28/07/2010 | 18/05/2010 | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients with Lymphangioleiomyomatosis. - ND | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients with Lymphangioleiomyomatosis. - ND | Lymphangioleiomyomatosis MedDRA version: 12.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis | INN or Proposed INN: Everolimus INN or Proposed INN: Everolimus INN or Proposed INN: Everolimus | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: no | 24 | France;Italy | |||
| 4 | EUCTR2010-019825-32-FR (EUCTR) | 29/06/2010 | 28/05/2010 | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients withLymphangioleiomyomatosis | An exploratory, open label, non-randomized, within-patient multiple dose-escalation safety, tolerability, PK and efficacy trial of RAD001 (everolimus) in patients withLymphangioleiomyomatosis | Lymphangioleiomyomatosis MedDRA version: 12.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis | Product Code: RAD001 INN or Proposed INN: everolimus Trade Name: Afinitor Product Code: RAD001 INN or Proposed INN: everolimus Trade Name: Afinitor Product Code: RAD001 INN or Proposed INN: everolimus | Novartis Pharma Service AG | NULL | Not Recruiting | Female: yes Male: no | 24 | France;Italy | |||
| 5 | 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 | |||
| 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 | NCT01059318 (ClinicalTrials.gov) | January 2010 | 28/1/2010 | A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis | An Exploratory, Open-label, Non-randomized, Within-patient Multiple Dose-escalation Safety, Tolerability, PK and Efficacy Trial of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis | Lymphangioleiomyomatosis | Drug: Everolimus | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | Female | 24 | Phase 2 | United States;France;Italy;Germany |
| 7 | 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 | |||
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 |
| 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 | 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 |
| 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 | EUCTR2005-001148-22-SK (EUCTR) | 27/06/2005 | 12/05/2005 | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | A 12-Months, Randomized, Double-Blind, Parallel-Group, Multicenter, Proof of Concept Study of the Efficacy of Oral RAD001 (6 mg/day) versus Azathioprine and Placebo in Crohn’s Disease - Not applicable | Crohn's disease MedDRA version: 7.1;Level: Low;Classification code 10011401 | Trade Name: Certican Product Name: Certican Product Code: RAD001 INN or Proposed INN: Everolimus Trade Name: Imuran Product Name: Imuran INN or Proposed INN: Azathioprine | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Slovakia |
| 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 | NCT03198949 (ClinicalTrials.gov) | May 24, 2018 | 13/6/2017 | A Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II) | A Prospective, Randomized, Double-blind, Placebo-controlled Cross Over Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II) | Epilepsy and Focal Cortical Dysplasia II | Drug: Afinitor (everolimus) | Yonsei University | NULL | Recruiting | 4 Years | 40 Years | All | 26 | Phase 2 | Korea, Republic of |
| 2 | 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 |
| 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 | NCT01997255 (ClinicalTrials.gov) | April 2014 | 15/11/2013 | Adjunctive Everolimus (RAD 001) Therapy for Epilepsy in Children With Sturge-Weber Syndrome (SWS) | An Open-Label Controlled Study of Adjunctive Everolimus (RAD 001) Therapy for Epilepsy in Children With Sturge-Weber Syndrome | Sturge Weber Syndrome | Drug: Everolimus | Baylor College of Medicine | Novartis Pharmaceuticals | Withdrawn | 2 Years | 18 Years | Both | 0 | Phase 2 | United States |
| 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 | 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 | Not yet recruiting | N/A | 2 Years | All | 96 | Phase 2;Phase 3 | France |
| 2 | 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 |
| 3 | 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] | Hospices Civils de Lyon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 146 | Phase 2;Phase 3 | France | |||
| 4 | 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] | 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 | |||
| 5 | 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 | ||
| 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 | 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 | ||
| 7 | 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 |
| 8 | 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] | Novartis Pharma AG | 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 | |||
| 9 | 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 | ||
| 10 | 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 | |
| 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 | 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 | ||
| 12 | 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 |
| 13 | 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 | ||
| 14 | 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 |
| 15 | 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 |
| 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 |
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | |
| 20 | 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 | ||
| 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 |
| 21 | 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 | ||
| 22 | 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 |
| 23 | 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] | 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;Italy;United Kingdom;Hungary;Canada;Argentina;Belgium;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of | |||
| 24 | 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 | ||
| 25 | 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 |
| 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 |
| 26 | 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 | ||||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 |
| 30 | 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 |
| 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 |
| 31 | 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 | ||||
| 32 | 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] | Cardiff University | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | United Kingdom | |||
| 33 | 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 | |||
| 34 | 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 | |||
| 35 | 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 | ||
| 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 |
| 36 | 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 | ||
| 37 | 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 | |||
| 38 | 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 | |||
| 39 | 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 | |||
| 40 | 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 | |||
| 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 |
| 41 | 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 | |||
| 42 | 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 |
| 43 | 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 | |||
| 44 | 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 |
| 45 | 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 | |||
| 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 |
| 46 | 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 |
| 47 | 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 | ||
| 48 | 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 |
| 49 | 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 |
| 50 | 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 | |||
| 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 |
| 51 | 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 | |||
| 52 | 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 | ||||
| 53 | 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 | |||
| 54 | 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 |
| 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 | EUCTR2004-001290-25-DE (EUCTR) | 17/08/2006 | 17/05/2006 | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungs | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLungs | Heart-lung, bilateral lung and single lung transplant recipientsMain ICD Classification Codes:J84.1, J43-44, E84.0, Z94.2 | INN or Proposed INN: Everolimus INN or Proposed INN: Everolimus INN or Proposed INN: Enteric coated mycophenolate sodium INN or Proposed INN: Ciclosporine A INN or Proposed INN: Ciclosporine A INN or Proposed INN: Ciclosporine A | St Vincent’s Hospital, Sydney, Australia | NULL | Not Recruiting | Female: yes Male: yes | 320 | United Kingdom;Germany;Spain | |||
| 2 | EUCTR2004-001290-25-GB (EUCTR) | 14/09/2005 | 16/08/2005 | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLung | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. - CeMyLung | Heart-Lung, bilateral lung and single lung transplant recipientsICD Classification: K01-K01.9, E53.9+Z94.1, E53.9+Z94.2, E53.9+Z94.3 | Trade Name: Certican Trade Name: Myfortic | St Vincent's Hospital | NULL | Not Recruiting | Female: yes Male: yes | 320 | Spain;Austria;Germany;United Kingdom | |||
| 3 | EUCTR2004-001290-25-AT (EUCTR) | 14/07/2005 | 06/09/2005 | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. (CERL080A2415) | A 3-Year Randomised, Open Label, Multi-Centre Investigator Driven Study Comparing de Novo Enteric Coated Mycophenolate Sodium with Delayed Onset Everolimus, Both Arms in Combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the Prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant Recipients. (CERL080A2415) | Patients between 18-65 years who have received either a single or bilateral lung transplant or a combined heart-lung transplant and who are suitable to receive triple immunosuppressive therapy with either mycophenolate sodium or everolimus, both arms in combination with cyclosporin and corticosteroids. | Product Name: Myfortic Product Code: ERL080 INN or Proposed INN: Mycophenolate Trade Name: Certican 0,5 mg Tabletten Product Name: Certican 0,5 Product Code: RAD001 INN or Proposed INN: Everolimus Trade Name: Certican 0,75mg Tabletten Product Name: Certican 0,75mg Product Code: RAD001 INN or Proposed INN: Everolimus | Prof Allan Glanville, St Vincents Hospital | NULL | Not Recruiting | Female: yes Male: yes | 320 | Spain;Austria;Germany;United Kingdom |
| 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 | JPRN-UMIN000014888 | 2014/06/01 | 19/08/2014 | Everolimus for the treatment of lymphangiomatosis, Gorham-Stout disease and vascular anomalies | Lymphangiomatosis, Gorham-Stout disease and vascular anomalies | Oral everolimus | Gifu university | NULL | Complete: follow-up complete | Not applicable | 30years-old | Male and Female | 30 | Phase 1 | Japan |