Oral LEVOSIMENDAN ( DrugBank: Levosimendan )


1 disease
IDDisease name (Link within this page)Number of trials
2Amyotrophic lateral sclerosis21

2. Amyotrophic lateral sclerosis


Clinical trials : 645 Drugs : 589 - (DrugBank : 163) / Drug target genes : 150 - Drug target pathways : 225
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: 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;United Kingdom;Italy;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
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
7EUCTR2018-004180-31-IT
(EUCTR)
24/07/201918/01/2021An 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 PHARMANULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
8NCT03948178
(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 PharmaNULLCompleted18 Years120 YearsAll227Phase 3Spain
9EUCTR2018-004180-31-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
10EUCTR2018-004180-31-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
11EUCTR2018-004180-31-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 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-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
13EUCTR2017-002754-36-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: 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
14EUCTR2017-002754-36-IT
(EUCTR)
05/07/201801/10/2021Effects 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 PHARMANULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
15NCT03505021
(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
16EUCTR2017-002754-36-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
17EUCTR2017-002754-36-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
18EUCTR2017-002754-36-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
19EUCTR2017-002754-36-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 CorporationNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
20EUCTR2017-002754-36-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
21EUCTR2017-002754-36-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