2. Amyotrophic lateral sclerosis Clinical trials / Disease details


Clinical trials : 624 Drugs : 611 - (DrugBank : 160) / Drug target genes : 172 - Drug target pathways : 225

  
22 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2016-002629-13-BE
(EUCTR)
04/09/201721/04/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.1;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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom
2EUCTR2016-002629-13-PT
(EUCTR)
28/08/201704/05/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
3EUCTR2016-002629-13-NL
(EUCTR)
07/06/201714/03/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.1;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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom
4EUCTR2016-002629-13-GB
(EUCTR)
05/06/201709/02/2018An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom;Italy;Germany;Netherlands;Ireland;Spain;Belgium;Canada;United States;France;Portugal
5EUCTR2016-002629-13-FR
(EUCTR)
22/05/201716/05/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;France;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
6EUCTR2016-002629-13-ES
(EUCTR)
12/04/201710/03/2017An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS Amyotrophic Lateral Sclerosis (ALS)
MedDRA version: 19.1;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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
7EUCTR2016-002629-13-IE
(EUCTR)
28/02/201725/11/2016An Open-Label Extension Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients with Amyotrophic Lateral Sclerosis (ALS) who Completed VITALITY-ALS (CY 4031) - VIGOR-ALS 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
8EUCTR2014-005413-23-IE
(EUCTR)
30/11/201610/09/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
9NCT02936635
(ClinicalTrials.gov)
October 17, 201612/10/2016A Study for Patients Who Completed VITALITY-ALS (CY 4031)A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)Amyotrophic Lateral Sclerosis (ALS)Drug: tirasemtivCytokineticsNULLCompleted18 YearsN/AAll280Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom
10EUCTR2014-005413-23-IT
(EUCTR)
30/05/201616/02/2018Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) - - 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
CYTOKINETICS, INC.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Belgium;Italy;United Kingdom;Germany;Netherlands;Ireland;Spain
11EUCTR2014-005413-23-DE
(EUCTR)
20/05/201621/08/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
12EUCTR2014-005413-23-PT
(EUCTR)
09/05/201603/02/2016Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
13EUCTR2014-005413-23-BE
(EUCTR)
20/04/201626/02/2016Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom
14EUCTR2014-005413-23-NL
(EUCTR)
06/04/201630/11/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom
15EUCTR2014-005413-23-ES
(EUCTR)
09/02/201610/12/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis (ALS)
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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot RecruitingFemale: yes
Male: yes
445Phase 3Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom
16EUCTR2014-005413-23-GB
(EUCTR)
01/12/201527/08/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year (VITALITY-ALS)A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis (ALS) 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: Tirasemtiv
Product Code: CK-2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Cytokinetics, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom
17NCT02496767
(ClinicalTrials.gov)
September 3, 201510/7/2015Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a YearA Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisDrug: Tirasemtiv;Drug: Placebo tabletsCytokineticsNULLCompleted18 YearsN/AAll744Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom
18EUCTR2012-004987-23-ES
(EUCTR)
12/06/201316/05/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;France;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
19EUCTR2012-004987-23-DE
(EUCTR)
29/04/201317/01/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
20EUCTR2012-004987-23-IE
(EUCTR)
08/02/201330/11/2012A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
700Phase 2United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
21EUCTR2012-004987-23-GB
(EUCTR)
24/01/201312/12/2012A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom
22EUCTR2012-004987-23-NL
(EUCTR)
07/02/2013A study in which patients suffering from amyotrophic lateral sclerosis (ALS) may be assigned randomly to receive either the treatment or placebo to look at how safe the product is, whether it has an effect and is easy to take.A Phase IIb, multi-national, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability and efficacy of CK-2017357 in patients with amyotrophic lateral sclerosis (ALS) Amyotrophic lateral sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: Tirasemtiv
Product Code: CK2017357
INN or Proposed INN: Tirasemtiv
Other descriptive name: 6-ethynyl-1-(pentan-3-yl)-1H-imidazo[4,5-b]pyrazin-2(3H)-one
Trade Name: Rilutek
Product Name: Riluzole
INN or Proposed INN: RILUZOLE
Cytokinetics IncNULLNot RecruitingFemale: yes
Male: yes
680Phase 2France;United States;Canada;Spain;Ireland;Germany;Netherlands;United Kingdom