89. Lymphangioleiomyomatosis Clinical trials / Disease details
Clinical trials : 39 / Drugs : 46 - (DrugBank : 20) / Drug target genes : 27 - Drug target pathways : 137
| 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 | EUCTR2020-000702-29-ES (EUCTR) | 07/06/2021 | 09/02/2021 | Evaluating the effect of Loratadine associated with Rapamune in Lymphagioleiomyomatosis (LAM). | Phase-II randomized clinical trial to evaluate the effect of Loratadine associated with Rapamune on Lymphagioleiomyomatosis (LAM). | EFFECT OF LORATADINE ON LYMPHANGIOLEIOMYOMATOSIS MedDRA version: 21.0;Level: PT;Classification code 10049459;Term: Lymphangioleiomyomatosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Loratadina STADA 10 mg Product Name: Loratadina Stada INN or Proposed INN: LORATADINE Other descriptive name: LORATADINE | IDIBELL (Institut d’Investigació Biomédica de Bellvitge) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 62 | Phase 2 | Spain | ||
| 2 | NCT04388371 (ClinicalTrials.gov) | October 18, 2019 | 11/5/2020 | Glutamine PET Imaging in LAM | Glutamine PET Imaging in LAM | Lymphangioleiomyomatosis (LAM) | Drug: Glutamine | Vanderbilt University Medical Center | The LAM Foundation | Completed | 18 Years | N/A | Female | 5 | Phase 1 | United States |
| 3 | NCT04273334 (ClinicalTrials.gov) | October 1, 2019 | 15/2/2020 | Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders | Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc. | Lymphatic Disorders | Drug: 68Ga-NEB | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 90 | Phase 1 | China |
| 4 | NCT03253913 (ClinicalTrials.gov) | March 31, 2018 | 10/8/2017 | Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial | Resveratrol and Sirolimus in Lymphangioleiomyomatosis Trial (RESULT) | Lymphangioleiomyomatosis | Drug: Sirolimus;Drug: Resveratrol | University of Cincinnati | National Heart, Lung, and Blood Institute (NHLBI) | Unknown status | 18 Years | N/A | Female | 25 | Phase 2 | United States |
| 5 | NCT03131999 (ClinicalTrials.gov) | January 23, 2018 | 24/4/2017 | LAM Pilot Study With Imatinib Mesylate | LAM Pilot Study With Imatinib Mesylate | Lymphangioleiomyomatosis | Drug: Imatinib Mesylate 400Mg Capsule;Drug: Placebo - Capsule | Medical University of South Carolina | Columbia University | Completed | 18 Years | N/A | All | 18 | Phase 1/Phase 2 | United States |
| 6 | NCT03150914 (ClinicalTrials.gov) | January 1, 2018 | 10/5/2017 | Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial | Multicenter Interventional Lymphangioleiomyomatosis (LAM) Early Disease Trial | LAM;Lymphangioleiomyomatosis | Drug: Sirolimus | University of Cincinnati | National Heart, Lung, and Blood Institute (NHLBI);National Center for Advancing Translational Science (NCATS);The LAM Foundation | Recruiting | 18 Years | N/A | Female | 60 | Phase 3 | United States |
| 7 | NCT03062943 (ClinicalTrials.gov) | October 2016 | 7/10/2016 | A Study of Nintedanib for LymphAngioleioMyomatosis (LAM) | A Pilot Study of Nintedanib for LymphAngioleioMyomatosis (LAM) | Lymphangioleiomyomatosis | Drug: Nintedanib | IRCCS Multimedica | NULL | Recruiting | 18 Years | N/A | Female | 30 | Phase 2 | Italy |
| 8 | NCT02484664 (ClinicalTrials.gov) | June 15, 2016 | 25/6/2015 | COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC | COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC | Lymphangioleiomyomatosis (LAM) | Drug: Celecoxib | Brigham and Women's Hospital | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | 70 Years | Female | 12 | Phase 2 | United States |
| 9 | NCT02737202 (ClinicalTrials.gov) | April 2016 | 31/3/2016 | Safety and Efficacy of Saracatinib In Subjects With Lymphangioleiomyomatosis | Safety and Efficacy of Saracatinib In Subjects With Lymphangioleiomyomatosis | Pulmonary Lymphangioleiomyomatosis | Drug: saracatinib | Baylor College of Medicine | University of Cincinnati;Brigham and Women's Hospital;Stanford University;Loyola University;University of South Florida;National Institutes of Health (NIH) | Terminated | 18 Years | 65 Years | Female | 28 | Phase 2 | United States |
| 10 | EUCTR2015-004919-20-IT (EUCTR) | 09/03/2016 | 11/08/2016 | A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) | A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) - A pilot study of nintedanib for lymphangioleiomyomatosis (LAM) | Female subjects affected by Llymphangioleiomyomatosis (LAM) MedDRA version: 19.0;Level: PT;Classification code 10049459;Term: Lymphangioleiomyomatosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev | MULTIMEDICA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | 30 | Phase 3 | Italy | ||
| 11 | 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 | Recruiting | 18 Years | N/A | Female | 600 | United States | |
| 12 | JPRN-UMIN000016677 | 2015/01/01 | 02/03/2015 | Efficacy and safety of low dose sirolimus in lymphangioleiomyomatosis | lymphangioleiomyomatosis | sirolimus 1mg/day / sirolimus 2mg/day | National Hospital Organization Kinki-chuo Chest Medical Center | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not selected | Japan | |
| 13 | NCT02116712 (ClinicalTrials.gov) | August 2014 | 15/4/2014 | The Tolerability of Saracatinib in Subjects With Lymphangioleiomyomatosis (LAM) (SLAM-1) | The Tolerability of Saracatinib in Subjects With Lymphangioleiomyomatosis (LAM) (SLAM-1) | Pulmonary Lymphangioleiomyomatosis | Drug: Saracatinib | Tony Eissa | University of Texas;University of Cincinnati | Completed | 18 Years | 65 Years | Both | 9 | Phase 1 | United States |
| 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 | NCT01799538 (ClinicalTrials.gov) | June 10, 2013 | 23/2/2013 | Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis | Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis | Lymphangioleiomyomatosis | Drug: albuterol inhaler;Drug: albuterol nebulizer;Procedure: PFT | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 18 Years | N/A | Female | 100 | Phase 1/Phase 2 | United States |
| 16 | JPRN-JMA-IIA00096 | 05/09/2012 | 17/08/2012 | multicenter lymphangioleiomyomatosis sirolimus trial for safety | multicenter lymphangioleiomyomatosis sirolimus trial for safety | lymphangioleiomyomatosis | Intervention type:DRUG. Intervention1:Srolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years and modified dosage between 1mg and 3mg QD depend on the plasma concentration monitoring.. | Koh Nakata, MD, PhD | Yoshikazu InoueKuniaki SeyamaRyushi TazawaToshinori Takada | Completed | >=18 YEARS | No Limit | Female | 65 | Phase 2 | Japan |
| 17 | NCT01687179 (ClinicalTrials.gov) | September 2012 | 2/8/2012 | Safety Study of Sirolimus and Hydroxychloroquine in Women With Lymphangioleiomyomatosis | Targeting Autophagy for the Treatment of TSC and LAM: a Phase I Trial of Hydroxychloroquine and Sirolimus | Lymphangioleiomyomatosis | Drug: Sirolimus and Hydroxychloroquine 200 mg;Drug: Sirolimus and Hydroxychloroquine 400 mg | Brigham and Women's Hospital | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | 85 Years | Female | 14 | Phase 1 | United States |
| 18 | JPRN-UMIN000007387 | 2012/03/31 | 01/04/2012 | Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis | Clinical trials for long-term administration of sirolimus for lymphangioleiomyomatosis - Long-term administration of sirolimus for lymphangioleiomyomatosis | lymphangioleiomyomatosis | sirolimus | Kobe University Graduate School of Medicine | NULL | Complete: follow-up complete | Not applicable | Not applicable | Female | 1 | Not applicable | Japan |
| 19 | NCT01552434 (ClinicalTrials.gov) | March 16, 2012 | 7/3/2012 | Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease | A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination With Valproic Acid, or Cetuximab in Patients With Advanced Malignancy and Other Indications | Advanced Malignant Neoplasm;Castleman Disease;Digestive System Carcinoma;Erdheim-Chester Disease;Lip and Oral Cavity Carcinoma;Lymphangioleiomyomatosis;Malignant Endocrine Neoplasm;Malignant Female Reproductive System Neoplasm;Malignant Male Reproductive System Neoplasm;Malignant Neoplasm;Malignant Respiratory Tract Neoplasm;Malignant Thoracic Neoplasm;Malignant Urinary System Neoplasm;Mesothelial Neoplasm;Metastatic Malignant Neoplasm;Metastatic Urothelial Carcinoma;Neurofibromatosis Type 2;Recurrent Adult Soft Tissue Sarcoma;Recurrent Breast Carcinoma;Recurrent Childhood Soft Tissue Sarcoma;Recurrent Digestive System Carcinoma;Recurrent Female Reproductive System Carcinoma;Recurrent Male Reproductive System Carcinoma;Recurrent Malignant Neoplasm;Recurrent Pharyngeal Carcinoma;Recurrent Thyroid Gland Carcinoma;Refractory Malignant Neoplasm;Soft Tissue Neoplasm;Stage III Breast Cancer AJCC v7;Stage III Pharyngeal Cancer;Stage IIIA Breast Cancer AJCC v7;Stage IIIB Breast Cancer AJCC v7;Stage IIIC Breast Cancer AJCC v7;Stage IV Breast Cancer AJCC v6 and v7;Stage IV Pharyngeal Cancer;Stage IVA Pharyngeal Cancer;Stage IVB Pharyngeal Cancer;Stage IVC Pharyngeal Cancer;Thyroid Gland Neoplasm | Biological: Bevacizumab;Biological: Cetuximab;Other: Laboratory Biomarker Analysis;Other: Pharmacological Study;Drug: Temsirolimus;Drug: Valproic Acid | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | Active, not recruiting | N/A | N/A | All | 155 | Phase 1 | United States |
| 20 | JPRN-JMA-IIA00037 | 01/10/2011 | 15/03/2010 | MLLTS trial | Multicenter Lymphangioleiomyomatosis Long Term Sirolimus Trial | lymphangioleiomyomatosis | Intervention type:DRUG. Intervention1:sirolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:LAM patients will be medicated with 2mg of sirolimus every day for 2 years.. | Koh Nakata, MD, Ph.D | Ryushi Tazawa | Other | >=18 YEARS | No Limit | Female | 50 | Phase 2 | Japan |
| 21 | NCT01353209 (ClinicalTrials.gov) | May 2011 | 11/5/2011 | Trial of Aromatase Inhibition in Lymphangioleiomyomatosis | A TRIAL OF LETROZOLE IN PULMONARY LYMPHANGIOLEIOMYOMATOSIS | Lymphangioleiomyomatosis | Drug: Letrozole;Drug: Placebo | University of Cincinnati | Department of Defense | Completed | 18 Years | N/A | Female | 17 | Phase 2 | United States |
| 22 | 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 | |||
| 23 | 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 | |||
| 24 | 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 | |||
| 25 | 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 |
| 26 | 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 | |||
| 27 | 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 | ||
| 28 | NCT00989742 (ClinicalTrials.gov) | July 2009 | 2/10/2009 | Doxycycline In Lymphangioleiomyomatosis (LAM) | A Randomised, Double Blind, Placebo Controlled Trial of Doxycycline in Lymphangioleiomyomatosis. | Lymphangioleiomyomatosis;Tuberous Sclerosis | Drug: Doxycycline;Drug: Placebo | University of Nottingham | NULL | Completed | 18 Years | N/A | Female | 24 | Phase 4 | United Kingdom |
| 29 | 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 |
| 30 | 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 | ||
| 31 | EUCTR2007-003745-32-GB (EUCTR) | 12/12/2008 | 26/11/2010 | A randomised, double blind, placebo controlled trial of doxycycline in lymphangioleiomyomatosis. - Doxycycline in LAM | A randomised, double blind, placebo controlled trial of doxycycline in lymphangioleiomyomatosis. - Doxycycline in LAM | Lymphangioleiomyomatosis MedDRA version: 9.1;Level: LLT;Classification code 10049459;Term: Lymphangioleiomyomatosis MedDRA version: 9.1;Level: PT;Term: Lymphangioleiomyomatosis | Trade Name: Doxycycline 100 mg Capsules INN or Proposed INN: doxycycline | University of Nottingham | NULL | Not Recruiting | Female: yes Male: no | United Kingdom | ||||
| 32 | 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 |
| 33 | JPRN-JMA-IIA00011 | 08/05/2008 | 29/06/2007 | Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial) | Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus Trial (The MILES Trial) | Lymphangioleiomyomatosis (LAM) | Intervention type:DRUG. Intervention1:Sirolimus, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:12 months on, 12 months off. Control intervention1:Placebo, Dose form:TABLET, Route of administration:ORAL, Intended dose regimen:12 months on, 12 months off. | Frank McCormack, M.D., University of Cincinnati Medical Center Director, Division of Pulmonary and Critical Care Medicine | a.Alan F. Barker, M.D. - Oregon Health & Sciences University b.Kevin Brown, M.D., - National Jewish Medical & Research Center c.Edwin K. Silverman, M.D., Ph.D. - Harvard/Brigham & Women's Hospital d.James M. Stocks, M.D. - University of Texas Health Centere.James K. Stoller, M.D. - Cleveland Clinic Foundation f.Charlie Strange, M.D. - Medical University of South Carolina g.Bruce Trapnell, M.D.-Cincinnati Children's Medical Centerh.Mark Brantly, M.D.-University of Florida, Gainesvillei.Yosdhikazu Inoue, M.D., National Hospital Organization (NHO) Kinki-Chuo Chest Medical Centerj.Koh Nakata, M.D., Ph.D., Bioscience Medical Research Center, Niigata University Medical and Dental Hospitalk.Joel Moss, M.D., Ph.D-National Institutes of Health | Completed | >=18 YEARS | Female | 120 | Phase 3 | Japan, United States, Canada | |
| 34 | NCT00414648 (ClinicalTrials.gov) | December 2006 | 20/12/2006 | Efficacy and Safety of Sirolimus for Treating Lymphangioleiomyomatosis (LAM) | Lymphangioleiomyomatosis Efficacy and Safety Trial | Lymphangioleiomyomatosis | Drug: Sirolimus;Drug: Placebo sirolimus | Office of Rare Diseases (ORD) | FDA Office of Orphan Products Development | Active, not recruiting | 18 Years | N/A | Female | 120 | Phase 3 | United States;Canada;Japan |
| 35 | NCT00490789 (ClinicalTrials.gov) | October 2005 | 21/6/2007 | Trial of Efficacy and Safety of Sirolimus in Tuberous Sclerosis and LAM | A Trial of the Efficacy and Safety of Sirolimus(Rapamycin)Therapy for Renal Angiomyolipmoas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis | Tuberous Sclerosis;Lymphangioleiomyomatosis | Drug: sirolimus | Cardiff University | University of Nottingham;St Georges Hospital Medical School;Royal Sussex County Hospital;The Tuberous Sclerosis Association;Wyeth is now a wholly owned subsidiary of Pfizer | Active, not recruiting | 18 Years | 65 Years | Both | 14 | Phase 2 | United Kingdom |
| 36 | NCT00457964 (ClinicalTrials.gov) | August 2005 | 6/4/2007 | RAD001 Therapy of Angiomyolipomata in Patients With TS Complex and Sporadic LAM | RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis | Tuberous Sclerosis;Lymphangioleiomyomatosis | Drug: RAD001 | Children's Hospital Medical Center, Cincinnati | Novartis Pharmaceuticals | Completed | 18 Years | 65 Years | Both | 36 | Phase 1/Phase 2 | United States |
| 37 | NCT00457808 (ClinicalTrials.gov) | December 2002 | 6/4/2007 | Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM | Rapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis | Tuberous Sclerosis;Lymphangioleiomyomatosis | Drug: Rapamycin, sirolimus | Children's Hospital Medical Center, Cincinnati | The LAM Foundation;Tuberous Sclerosis Alliance | Completed | 18 Years | 65 Years | Both | 25 | Phase 2 | United States |
| 38 | NCT00005906 (ClinicalTrials.gov) | June 2000 | 9/6/2000 | Treatment With Octreotide in Patients With Lymphangioleiomyomatosis | Treatment With Octreotide in Patients With Lymphangioleiomyomatosis | Lymphangioleiomyomatosis;Lymphangiomyomas;Pleural Effusions;Ascites | Drug: Octreotide | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | 18 Years | 65 Years | Female | 4 | Phase 2 | United States |
| 39 | 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 |