2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| 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 | EUCTR2018-004180-31-FR (EUCTR) | 31/01/2020 | 07/11/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2018-004180-31-IE (EUCTR) | 16/12/2019 | 02/08/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2018-004180-31-NL (EUCTR) | 02/10/2019 | 23/07/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2018-004180-31-GB (EUCTR) | 05/09/2019 | 01/11/2019 | An open label extension for patients completing study 3119002 to studythe effects of oral Levosimendan on breathing function in patients with thedisease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 5 | EUCTR2018-004180-31-AT (EUCTR) | 22/08/2019 | 03/05/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2018-004180-31-FI (EUCTR) | 15/08/2019 | 25/04/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 7 | EUCTR2018-004180-31-IT (EUCTR) | 24/07/2019 | 18/01/2021 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: [ODM-109] INN or Proposed INN: LEVOSIMENDAN | ORION CORPORATION ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 8 | NCT03948178 (ClinicalTrials.gov) | June 26, 2019 | 7/5/2019 | Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension | Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002 | Amyotrophic Lateral Sclerosis | Drug: Levosimendan | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 120 Years | All | 227 | Phase 3 | Spain |
| 9 | EUCTR2018-004180-31-DE (EUCTR) | 17/06/2019 | 12/04/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 10 | EUCTR2018-004180-31-ES (EUCTR) | 16/05/2019 | 12/04/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 11 | EUCTR2018-004180-31-BE (EUCTR) | 29/04/2019 | 15/03/2019 | An open label extension for patients completing study 3119002 to study the effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES | Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 12 | EUCTR2017-002754-36-FR (EUCTR) | 27/03/2019 | 27/11/2018 | Effects of oral levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 13 | EUCTR2017-002754-36-NL (EUCTR) | 30/08/2018 | 22/05/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 14 | EUCTR2017-002754-36-IT (EUCTR) | 05/07/2018 | 01/10/2021 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: [ODM-109] INN or Proposed INN: LEVOSIMENDAN | ORION CORPORATION ORION PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 15 | NCT03505021 (ClinicalTrials.gov) | June 21, 2018 | 16/4/2018 | Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS | Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS | Amyotrophic Lateral Sclerosis | Drug: Levosimendan;Drug: Placebo for levosimendan | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | 120 Years | All | 496 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Finland;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 16 | EUCTR2017-002754-36-BE (EUCTR) | 15/05/2018 | 28/02/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 17 | EUCTR2017-002754-36-IE (EUCTR) | 08/05/2018 | 25/01/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 18 | EUCTR2017-002754-36-GB (EUCTR) | 04/05/2018 | 30/01/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | Germany;Netherlands;Sweden;United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia | ||
| 19 | EUCTR2017-002754-36-ES (EUCTR) | 29/04/2018 | 14/03/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 20 | EUCTR2017-002754-36-FI (EUCTR) | 19/04/2018 | 28/02/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 21 | EUCTR2017-002754-36-AT (EUCTR) | 17/04/2018 | 08/03/2018 | Effects of oral Levosimendan on breathing function in patients with the disease Amyotrophic Lateral Sclerosis (ALS) | Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS - REFALS | Amyotrophic lateral sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Oral LEVOSIMENDAN Product Code: ODM-109 INN or Proposed INN: LEVOSIMENDAN | Orion Corporation | NULL | Not Recruiting | Female: yes Male: yes | 496 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden |