Leucine (DrugBank: Leucine)
10 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 5 | 進行性核上性麻痺 | 1 |
| 6 | パーキンソン病 | 1 |
| 7 | 大脳皮質基底核変性症 | 1 |
| 19 | ライソゾーム病 | 9 |
| 96 | クローン病 | 1 |
| 97 | 潰瘍性大腸炎 | 1 |
| 127 | 前頭側頭葉変性症 | 1 |
| 283 | 後天性赤芽球癆 | 1 |
| 284 | ダイアモンド・ブラックファン貧血 | 2 |
| 299 | 嚢胞性線維症 | 2 |
| 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 | NCT03545126 (ClinicalTrials.gov) | August 21, 2017 | 12/3/2018 | Human CNS Tau Kinetics in Tauopathies | Human CNS Tau Kinetics in Tauopathies | Progressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation) | Other: 13C6 Leucine | Washington University School of Medicine | Association of Frontotemporal Degeneration;Tau Consortium | Recruiting | 18 Years | N/A | All | 32 | 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 | NCT02263235 (ClinicalTrials.gov) | June 2013 | 18/9/2014 | In Vivo Alzheimer Proteomics | Use of Targeted Quantitative Proteomics and Metabolic Labelling With Stable Isotopes for the Diagnosis and the Investigation of Neurological Disorders and in Particular Alzheimer Disease | Probable Alzheimer Disease;Parkinson Disease;Neurological Disease Without Cognitive Degradation;Brain Trauma;Acute Hydrocephaly | Biological: administration of stable isotope-labelled leucine-;Other: collection of CSF, blood, urine, saliva | University Hospital, Montpellier | Assistance Publique - Hôpitaux de Paris;University Hospital, Clermont-Ferrand;International Atomic Energy Agency | Recruiting | 55 Years | 85 Years | Both | 110 | N/A | France |
| 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 | NCT03545126 (ClinicalTrials.gov) | August 21, 2017 | 12/3/2018 | Human CNS Tau Kinetics in Tauopathies | Human CNS Tau Kinetics in Tauopathies | Progressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation) | Other: 13C6 Leucine | Washington University School of Medicine | Association of Frontotemporal Degeneration;Tau Consortium | Recruiting | 18 Years | N/A | All | 32 | 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 | NCT03759639 (ClinicalTrials.gov) | September 4, 2019 | 27/11/2018 | N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC) | Effects of N-Acetyl-L-Leucine on Niemann Pick Type C Disease: A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study. | Niemann-Pick Disease, Type C | Drug: IB1001 | IntraBio Inc | NULL | Active, not recruiting | 6 Years | N/A | All | 34 | Phase 2 | United States;Germany;Slovakia;Spain;United Kingdom |
| 2 | EUCTR2018-004406-25-GB (EUCTR) | 20/06/2019 | 06/02/2020 | To demonstrate that N-Acetyl-L-Leucine is effective in improving symptoms, functioning and quality of life in patients with GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). | Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and SandhoffDisease): A multinational, multicenter, open-label, rater-blinded Phase II study - IB1001-202 | To demonstrate that N-Acetyl-L-Leucine is effective in improvingsymptoms, functioning, and quality of life in patients GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). MedDRA version: 20.0;Level: PT;Classification code 10043147;Term: Tay-Sachs disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10081314;Term: Sandhoff disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: SUB195712 Other descriptive name: N-Acetyl-L-Leucine Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-leucine Other descriptive name: N-Acetyl-L-Leucine | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Spain;Germany;United Kingdom | ||
| 3 | EUCTR2018-004331-71-GB (EUCTR) | 20/06/2019 | 14/01/2019 | To demonstrate that N-Acetyl-L-Leucine is effective in improving symptoms, functioning and quality of life in patients with Niemann-Pick Type C disease (NPC). | Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C: A multinational,multicenter, open-label, rater-blinded Phase II study. - IB1001-201Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease | To demonstrate that N-Acetyl-L-Leucine is effective in improvingsymptoms, functioning, and quality of life in patients withNiemann-Pick Type C disease (NPC). MedDRA version: 20.0;Level: PT;Classification code 10029403;Term: Niemann-Pick disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: SUB195712 Other descriptive name: N-Acetyl-L-Leucine Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-leucine Other descriptive name: N-Acetyl-L-Leucine | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Slovakia;Spain;Germany;United Kingdom | ||
| 4 | EUCTR2018-004331-71-ES (EUCTR) | 10/06/2019 | 22/01/2019 | A safety and efficacy study of N-Acetyl-L-Leucine on Niemann-Pick type C Disease. | Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study | Niemann-Pick Disease type C (NPC) MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Slovakia;Spain;Germany;United Kingdom | |||
| 5 | EUCTR2018-004406-25-ES (EUCTR) | 10/06/2019 | 12/04/2019 | A safety and efficacy study of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). | Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A multinational, multicenter, open-label, rater-blinded Phase II study. | GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Spain;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 |
| 6 | NCT03759665 (ClinicalTrials.gov) | June 7, 2019 | 27/11/2018 | N-Acetyl-L-Leucine for GM2 Gangliosdisosis (Tay-Sachs and Sandhoff Disease) | Effects of N-Acetyl-L-Leucine on GM2 Gangliosdisosis (Tay-Sachs and Sandhoff Disease): A Multinational, Multicenter, Open-label, Rater-blinded Phase II Study | GM2 Gangliosidosis;Tay-Sachs Disease;Sandhoff Disease | Drug: IB1001 | IntraBio Inc | NULL | Recruiting | 6 Years | N/A | All | 39 | Phase 2 | United States;Germany;Spain;United Kingdom |
| 7 | EUCTR2018-004331-71-SK (EUCTR) | 04/06/2019 | 30/01/2019 | A safety and efficacy study of N-Acetyl-L-Leucine on Niemann-Pick type C Disease. | Effects of N-Acetyl-L-Leucine on Niemann-Pick disease type C: A multinational, multicenter, open-label, rater-blinded Phase II study. | Niemann-Pick Disease type C (NPC) MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: PT;Classification code 10029403;Term: Niemann-Pick disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Slovakia;Spain;Germany;United Kingdom | |||
| 8 | EUCTR2018-004406-25-DE (EUCTR) | 09/05/2019 | 23/01/2019 | A safety and efficacy study of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease). | Effects of N-Acetyl-L-Leucine on GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease): A multinational, multicenter, open-label, rater-blinded Phase II study. | GM2 Gangliosidosis (Tay-Sachs and Sandhoff Disease) MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-Leucine Other descriptive name: 2(S)-(ACETYLAMINO)-4-METHYLPENTANOIC ACID Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-Leucine Other descriptive name: 2(S)-(ACETYLAMINO)-4-METHYLPENTANOIC ACID | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Spain;Germany;United Kingdom | ||
| 9 | EUCTR2018-004331-71-DE (EUCTR) | 08/05/2019 | 02/01/2019 | A safety and efficacy study of N-Acetyl-L-Leucine on Niemann-Pick type C Disease. | Effects of N-Acetyl-L-Leucine on Niemann-Pick type C Disease (NPC): A multinational, multi-center, open-label, rater-blinded Phase II study | Niemann-Pick Disease type C (NPC) MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-leucine Other descriptive name: 2(S)-(ACETYLAMINO)-4-METHYLPENTANOIC ACID Product Name: N-Acetyl-L-Leucine Product Code: IB1001 INN or Proposed INN: N-Acetyl-L-leucine Other descriptive name: 2(S)-(ACETYLAMINO)-4-METHYLPENTANOIC ACID | IntraBio Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 39 | Phase 2 | United States;Slovakia;Spain;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 | NCT04535882 (ClinicalTrials.gov) | October 1, 2020 | 28/8/2020 | Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD | Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Ulcerative Colitis or Crohn's Disease Colitis | LRG Levels | Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels | Showa Inan General Hospital | NULL | Recruiting | N/A | N/A | All | 100 | 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 | NCT04535882 (ClinicalTrials.gov) | October 1, 2020 | 28/8/2020 | Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD | Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Ulcerative Colitis or Crohn's Disease Colitis | LRG Levels | Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels | Showa Inan General Hospital | NULL | Recruiting | N/A | N/A | All | 100 | 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 | NCT03545126 (ClinicalTrials.gov) | August 21, 2017 | 12/3/2018 | Human CNS Tau Kinetics in Tauopathies | Human CNS Tau Kinetics in Tauopathies | Progressive Supranuclear Palsy (PSP);Corticobasal Degeneration (CBD);Frontotemporal Dementia (FTD MAPT Mutation) | Other: 13C6 Leucine | Washington University School of Medicine | Association of Frontotemporal Degeneration;Tau Consortium | Recruiting | 18 Years | N/A | All | 32 | 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 | NCT01362595 (ClinicalTrials.gov) | June 2013 | 20/5/2011 | Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia | The Use of Novel Therapies to Reconstitute Blood Cell Production and Promote Organ Performance Using Bone Marrow Failure as a Model: a Pilot, Phase I/II Study of the Amino Acid Leucine in the Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia | Diamond Blackfan Anemia;Blackfan Diamond Syndrome;DBA;Congenital Hypoplastic Anemia;Pure Red Cell Aplasia | Drug: leucine | Northwell Health | NULL | Active, not recruiting | 2 Years | N/A | All | 50 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02386267 (ClinicalTrials.gov) | September 2014 | 18/2/2015 | L-leucine in Diamond Blackfan Anemia Patients | Therapeutic Use of the Amino Acid Leucine in the Treatment of Transfusion-Dependent Diamond Blackfan Anemia Patients | Diamond Blackfan Anemia | Drug: L-leucine | Federal Scientific Clinical Centre of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogache | NULL | Recruiting | 1 Year | 20 Years | Both | 30 | Phase 2 | Russian Federation |
| 2 | NCT01362595 (ClinicalTrials.gov) | June 2013 | 20/5/2011 | Pilot Phase I/II Study of Amino Acid Leucine in Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia | The Use of Novel Therapies to Reconstitute Blood Cell Production and Promote Organ Performance Using Bone Marrow Failure as a Model: a Pilot, Phase I/II Study of the Amino Acid Leucine in the Treatment of Patients With Transfusion-Dependent Diamond Blackfan Anemia | Diamond Blackfan Anemia;Blackfan Diamond Syndrome;DBA;Congenital Hypoplastic Anemia;Pure Red Cell Aplasia | Drug: leucine | Northwell Health | NULL | Active, not recruiting | 2 Years | N/A | All | 50 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01172301 (ClinicalTrials.gov) | July 2008 | 27/7/2010 | Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis | Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Essential amino acid intake + Leucine vs total AA supplement | Texas A&M University | Arkansas Children's Hospital Research Institute | Completed | 10 Years | 21 Years | Both | 14 | N/A | United States |
| 2 | NCT00014768 (ClinicalTrials.gov) | February 2001 | 10/4/2001 | Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis | Cystic Fibrosis | Drug: glucose;Drug: insulin;Drug: leucine | National Center for Research Resources (NCRR) | University of Utah | Terminated | N/A | N/A | Female | 36 | N/A | United States |