2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
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 | EUCTR2020-003376-40-SE (EUCTR) | 23/02/2022 | 29/12/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 2 | JPRN-jRCT2071210117 | 23/02/2022 | 21/01/2022 | Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in subjects with Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | - Oral edaravone administered once daily for up to 48 weeks or until the drug is commercially available in that country - Oral edaravone administered for 10 days followed by 18-day placebo (regimen denoted as on/off) for up to 48 weeks or until the drug is commercially available in that country | Kondo Kazuoki | NULL | Recruiting | >= 18age old | Not applicable | Both | 300 | Phase 3 | US;Canada;Germany;Italia;South Korea;Switzerland;Japan |
| 3 | EUCTR2020-003376-40-DE (EUCTR) | 26/10/2021 | 16/06/2021 | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2020-003376-40-IE (EUCTR) | 12/10/2021 | 10/06/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2020-003376-40-ES (EUCTR) | 05/10/2021 | 23/06/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE (ALS Deceleration with ORal Edaravone) study | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Poland;Belgium;Spain;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2020-003376-40-IT (EUCTR) | 28/09/2021 | 19/10/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - - | Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: [FAB122] INN or Proposed INN: Edaravone Other descriptive name: Norphenazone; methylphenylpyrazolone; norantipyrine; 3-methyl-1-phenyl-4, 5-dihydro-1H-pyrazol-5-one. | Ferrer Internacional S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2020-003376-40-PL (EUCTR) | 18/08/2021 | 09/07/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;France;Spain;Belgium;Poland;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 8 | EUCTR2020-003376-40-BE (EUCTR) | 10/08/2021 | 08/06/2021 | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 9 | EUCTR2020-000376-38-DE (EUCTR) | 06/07/2021 | 19/01/2021 | A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) | 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: Edaravone Product Code: MT-1186 INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Canada;Germany;Italy;Japan | ||
| 10 | EUCTR2019-004256-11-DE (EUCTR) | 11/05/2021 | 17/11/2020 | An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) | 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: Edaravone Product Code: MT-1186 INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of | ||
| 11 | EUCTR2019-004256-11-IT (EUCTR) | 22/03/2021 | 24/05/2021 | An Efficacy and Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - N/A | 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: Edaravone Product Code: [MT-1186] | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 3 | France;United States;Canada;Germany;Switzerland;Japan;Italy;Korea, Republic of | ||
| 12 | EUCTR2020-000376-38-IT (EUCTR) | 22/03/2021 | 24/05/2021 | A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered over 96 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - MT-1186-A03 | 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: Edaravone Product Code: [MT-1186] INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Canada;Germany;Japan;Italy | ||
| 13 | JPRN-jRCT2031200361 | 26/02/2021 | 15/02/2021 | Comparative Bioavailability study of Oral Edaravone Administered orally and via a Nasogastric Tube | A Phase I, Randomized, Open-Label, Crossover-Design, Single-Dose Study to Investigate the Safety, Tolerability and Comparative Bioavailability of Oral Edaravone Administered orally and via a Nasogastric Tube (NGT) in Healthy Adult Subjects | Amyotrophic Lateral Sclerosis | Subjects will receive the edaravone oral suspension orally. And, subjects will receive the edaravone oral suspension via a NGT. | Kondo Kazuoki | NULL | Complete | >= 20age old | <= 45age old | Both | 36 | Phase 1 | Japan |
| 14 | JPRN-jRCT2031200301 | 25/01/2021 | 15/01/2021 | Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Group 1: Oral edaravone administered once daily for 28 days, in Cycles 1 through 12 Group 2: Oral edaravone administered for 14 days, followed by placebo for 14 days in Cycle 1. Subsequently, repeat oral edaravone administered for 10 days followed by placebo for 18 days (regimen denoted as on/off) in Cycles 2 through 12 | Kondo Kazuoki | NULL | Recruiting | >= 18age old | <= 75age old | Both | 380 | Phase 3 | Korea;Germany;United States of America;Canada;France;Switzerland;Italy;Japan |
| 15 | JPRN-jRCT2041200084 | 23/12/2020 | 24/12/2020 | Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period | Kondo Kazuoki | NULL | Recruiting | >= 18age old | Not applicable | Both | 140 | Phase 3 | United States of America;Canada;Germany;France;Italy;Japan |
| 16 | NCT04569084 (ClinicalTrials.gov) | November 13, 2020 | 23/9/2020 | Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS | A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | ALS | Drug: MT-1186;Drug: Placebo | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Recruiting | 18 Years | 75 Years | All | 380 | Phase 3 | United States;Canada;Germany;Italy;Japan;Korea, Republic of;Switzerland |
| 17 | NCT04391361 (ClinicalTrials.gov) | November 1, 2020 | 13/5/2020 | The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of ALS | The Safety and Effectiveness of Cholinergic Receptor Block Therapy in the Treatment of Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis;Respiratory Function;Scopolamine | Drug: Scopolamine, atropine, edaravone and dexmedetomidine;Drug: Edaravone | Ruijin Hospital | NULL | Not yet recruiting | 30 Years | 65 Years | All | 30 | Phase 2 | China |
| 18 | NCT04577404 (ClinicalTrials.gov) | October 29, 2020 | 30/9/2020 | Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: MT-1186 | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Recruiting | 18 Years | N/A | All | 140 | Phase 3 | United States;Canada;France;Germany;Italy;Japan |
| 19 | EUCTR2019-002108-41-DE (EUCTR) | 06/05/2020 | 17/01/2020 | A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) | 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: Edaravone Product Code: MT-1186 INN or Proposed INN: EDARAVONE | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;United States;Canada;Germany;Italy;Japan | ||
| 20 | EUCTR2019-002108-41-IT (EUCTR) | 24/04/2020 | 17/06/2021 | A Safety Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS) | A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS) - n/a | 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: Edaravone Product Code: [MT-1186] | Mitsubishi Tanabe Development America Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | France;United States;Canada;Germany;Japan;Italy | ||
| 21 | NCT04254913 (ClinicalTrials.gov) | January 24, 2020 | 23/1/2020 | Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy | Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy | Japanese Patients With ALS | Drug: MT-1186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 80 Years | All | 6 | Phase 1 | Japan |
| 22 | NCT04259255 (ClinicalTrials.gov) | October 21, 2019 | 27/1/2020 | Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS) | Radicava® (Edaravone) Findings in Biomarkers From ALS (REFINE-ALS) | Amyotrophic Lateral Sclerosis;ALS | Drug: Edaravone | Mitsubishi Tanabe Pharma America Inc. | Massachusetts General Hospital | Recruiting | 18 Years | N/A | All | 300 | United States;Canada | |
| 23 | NCT04176224 (ClinicalTrials.gov) | April 17, 2019 | 22/11/2019 | Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis | Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) | Japanese Patients With ALS | Drug: MT-1186 | Mitsubishi Tanabe Pharma Corporation | NULL | Completed | 20 Years | 75 Years | All | 9 | Phase 1 | Japan |
| 24 | NCT03272802 (ClinicalTrials.gov) | March 16, 2017 | 2/9/2017 | Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) | Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population | Neuromuscular Diseases | Drug: Edaravone;Drug: Riluzole | Isfahan University of Medical Sciences | NULL | Active, not recruiting | 18 Years | 75 Years | All | 20 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 25 | JPRN-UMIN000024854 | 2016/11/16 | 16/11/2016 | Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis | Clinical study of the effectiveness of edaravone for the oxidative stress in amyotrophic lateral sclerosis - Clinical study for the anti-oxidative stress by edaravone in ALS | Amyotrophic Lateral Sclerosis (ALS) | Edaravone treatment for ALS patients | Okayama university | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 20 | Not applicable | Japan |
| 26 | JPRN-UMIN000016352 | 2015/02/01 | 01/02/2015 | The Safety of Edaravone for patients with Amyotrophic Lateral Sclerosis: Single centered open label trial | amyotrophic lateral sclerosis | edaravone | Ehime University Hospital | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 10 | Phase 1,2 | Japan |