2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 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 | Sweden;Netherlands;Germany;Australia;Belgium;Canada;France;United Kingdom;Italy;Austria;Ireland;Spain;Finland;United States | ||
| 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 | Authorised-recruitment may be ongoing or finished | 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 | ||
| 22 | EUCTR2014-004567-21-NL (EUCTR) | 04/11/2015 | 04/08/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 18.1;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: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Ireland;Germany;Netherlands;United Kingdom | ||
| 23 | EUCTR2014-004567-21-DE (EUCTR) | 22/09/2015 | 09/03/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 19.0;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: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Ireland;Netherlands;Germany;United Kingdom | ||
| 24 | NCT02487407 (ClinicalTrials.gov) | July 2015 | 8/6/2015 | Effects of ODM-109 on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis | Effects of ODM-109 on Respiratory Function in Patients With ALS. A Randomized, Double Blind, Placebo-controlled, Cross-over, 3-period, Multicenter Study With Open-label Follow-up Extension | Amyotrophic Lateral Sclerosis | Drug: ODM-109;Drug: Placebo for ODM-109 | Orion Corporation, Orion Pharma | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | Germany;Ireland;Netherlands;United Kingdom |
| 25 | EUCTR2014-004567-21-IE (EUCTR) | 05/06/2015 | 05/03/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 19.0;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: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Ireland;Netherlands;Germany;United Kingdom | ||
| 26 | EUCTR2014-004567-21-GB (EUCTR) | 27/05/2015 | 10/03/2015 | Effects of ODM-109 on respiratory function in patients with ALS. | Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS | Amyotrophic lateral sclerosis (ALS). A rapidly progressive neurological disease characterized by degeneration of upper and lower motor neurons with subsequent muscle atrophy and weakness and loss of respiratory function. The latter is due to the weakness and loss of the diaphragm muscle strength. MedDRA version: 17.1;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: ODM-109 capsule 1 mg INN or Proposed INN: LEVOSIMENDAN | Orion Corporation Orion Pharma | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Ireland;Netherlands;Germany;United Kingdom |