Tirasemtiv ( DrugBank: Tirasemtiv )
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 : 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 | EUCTR2016-002629-13-BE (EUCTR) | 04/09/2017 | 21/04/2017 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2016-002629-13-PT (EUCTR) | 28/08/2017 | 04/05/2017 | An 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. | NULL | Not 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): no | France;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2016-002629-13-NL (EUCTR) | 07/06/2017 | 14/03/2017 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom | ||
| 4 | EUCTR2016-002629-13-GB (EUCTR) | 05/06/2017 | 09/02/2018 | An 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. | NULL | Not 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): no | United Kingdom;Italy;Germany;Netherlands;Ireland;Spain;Belgium;Canada;United States;France;Portugal | ||
| 5 | EUCTR2016-002629-13-FR (EUCTR) | 22/05/2017 | 16/05/2017 | An 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. | NULL | Not 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): no | Portugal;United States;France;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2016-002629-13-ES (EUCTR) | 12/04/2017 | 10/03/2017 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2016-002629-13-IE (EUCTR) | 28/02/2017 | 25/11/2016 | An 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. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2014-005413-23-IE (EUCTR) | 30/11/2016 | 10/09/2015 | Ventilatory 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 9 | NCT02936635 (ClinicalTrials.gov) | October 17, 2016 | 12/10/2016 | A 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: tirasemtiv | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 280 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom |
| 10 | EUCTR2014-005413-23-IT (EUCTR) | 30/05/2016 | 16/02/2018 | Ventilatory 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Belgium;Italy;United Kingdom;Germany;Netherlands;Ireland;Spain | ||
| 11 | EUCTR2014-005413-23-DE (EUCTR) | 20/05/2016 | 21/08/2015 | Ventilatory 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. | NULL | Not 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): no | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2014-005413-23-PT (EUCTR) | 09/05/2016 | 03/02/2016 | Ventilatory 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. | NULL | Not 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): no | France;United States;Portugal;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 13 | EUCTR2014-005413-23-BE (EUCTR) | 20/04/2016 | 26/02/2016 | Ventilatory 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 14 | EUCTR2014-005413-23-NL (EUCTR) | 06/04/2016 | 30/11/2015 | Ventilatory 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom | ||
| 15 | EUCTR2014-005413-23-ES (EUCTR) | 09/02/2016 | 10/12/2015 | Ventilatory 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. | NULL | Not Recruiting | Female: yes Male: yes | 445 | Phase 3 | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 16 | EUCTR2014-005413-23-GB (EUCTR) | 01/12/2015 | 27/08/2015 | Ventilatory 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. | NULL | Not 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): no | Portugal;France;United States;Canada;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 17 | NCT02496767 (ClinicalTrials.gov) | September 3, 2015 | 10/7/2015 | Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices After Treatment for a Year | 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 | Drug: Tirasemtiv;Drug: Placebo tablets | Cytokinetics | NULL | Completed | 18 Years | N/A | All | 744 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;United Kingdom |
| 18 | EUCTR2012-004987-23-ES (EUCTR) | 12/06/2013 | 16/05/2013 | A 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 2 | United States;France;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 19 | EUCTR2012-004987-23-DE (EUCTR) | 29/04/2013 | 17/01/2013 | A 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2 | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 20 | EUCTR2012-004987-23-IE (EUCTR) | 08/02/2013 | 30/11/2012 | A 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2 | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 21 | EUCTR2012-004987-23-GB (EUCTR) | 24/01/2013 | 12/12/2012 | A 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 Inc | NULL | Not 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): no | United States;Canada;Spain;Ireland;Netherlands;Germany;United Kingdom | ||
| 22 | EUCTR2012-004987-23-NL (EUCTR) | 07/02/2013 | A 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 Inc | NULL | Not Recruiting | Female: yes Male: yes | 680 | Phase 2 | France;United States;Canada;Spain;Ireland;Germany;Netherlands;United Kingdom |