Levosimendan    (DrugBank: Levosimendan)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症22

2. 筋萎縮性側索硬化症 [臨床試験数:508,薬物数:530(DrugBank:146),標的遺伝子数:170,標的パスウェイ数:221
Searched query = "Amyotrophic lateral sclerosis", "ALS"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
22 / 508 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004180-31-FR
(EUCTR)
31/01/202007/11/2019An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
2EUCTR2018-004180-31-IE
(EUCTR)
16/12/201902/08/2019An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
3EUCTR2018-004180-31-NL
(EUCTR)
02/10/201923/07/2019An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
4EUCTR2018-004180-31-GB
(EUCTR)
05/09/201901/11/2019An 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
5EUCTR2018-004180-31-AT
(EUCTR)
22/08/201903/05/2019An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-004180-31-FI
(EUCTR)
15/08/201925/04/2019An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
7NCT03948178
(ClinicalTrials.gov)
June 26, 20197/5/2019Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label ExtensionEffects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002Amyotrophic Lateral SclerosisDrug: LevosimendanOrion Corporation, Orion PharmaNULLActive, not recruiting18 Years120 YearsAll450Phase 3Spain
8EUCTR2018-004180-31-DE
(EUCTR)
17/06/201912/04/2019An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
9EUCTR2018-004180-31-ES
(EUCTR)
16/05/201912/04/2019An 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
10EUCTR2018-004180-31-BE
(EUCTR)
29/04/201915/03/2019An 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-002754-36-FR
(EUCTR)
27/03/201927/11/2018Effects 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
12EUCTR2017-002754-36-NL
(EUCTR)
30/08/201822/05/2018Effects 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
13NCT03505021
(ClinicalTrials.gov)
June 21, 201816/4/2018Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALSEffects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALSAmyotrophic Lateral SclerosisDrug: Levosimendan;Drug: Placebo for levosimendanOrion Corporation, Orion PharmaNULLCompleted18 Years120 YearsAll496Phase 3United States;Australia;Austria;Belgium;Canada;Finland;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
14EUCTR2017-002754-36-BE
(EUCTR)
15/05/201828/02/2018Effects 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
15EUCTR2017-002754-36-IE
(EUCTR)
08/05/201825/01/2018Effects 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-002754-36-GB
(EUCTR)
04/05/201830/01/2018Effects 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3Germany;Netherlands;Sweden;United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia
17EUCTR2017-002754-36-ES
(EUCTR)
29/04/201814/03/2018Effects 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Canada;Belgium;Australia;Germany;Netherlands;Sweden
18EUCTR2017-002754-36-FI
(EUCTR)
19/04/201828/02/2018Effects 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden
19EUCTR2017-002754-36-AT
(EUCTR)
17/04/201808/03/2018Effects 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
496Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
20EUCTR2014-004567-21-NL
(EUCTR)
04/11/201504/08/2015Effects 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Ireland;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-004567-21-DE
(EUCTR)
22/09/201509/03/2015Effects 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Ireland;Netherlands;Germany;United Kingdom
22EUCTR2014-004567-21-IE
(EUCTR)
05/06/201505/03/2015Effects 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 PharmaNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Ireland;Netherlands;Germany;United Kingdom