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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |