2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 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 | NCT05568615 (ClinicalTrials.gov) | October 26, 2022 | 2/10/2022 | Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS | Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS) | ALS | Drug: MT-1186 | Mitsubishi Tanabe Pharma Corporation | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | Japan |
| 2 | EUCTR2021-003900-42-DE (EUCTR) | 15/07/2022 | 17/03/2022 | Continued Efficacy and Safety Study of Oral Edaravone Following Study MT-1186-A02 in Subjects with Amyotrophic Lateral Sclerosis (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 (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 | 300 | Phase 3 | United States;Canada;Germany;Italy;Switzerland;Japan;Korea, Republic of | ||
| 3 | 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 |
| 4 | NCT05151471 (ClinicalTrials.gov) | January 11, 2022 | 28/11/2021 | 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) | ALS | Drug: MT-1186;Drug: Placebo | Mitsubishi Tanabe Pharma Development America, Inc. | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 3 | United States;Canada;Germany;Japan;Korea, Republic of;Switzerland;United Kingdom |
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | Active, not recruiting | 18 Years | 75 Years | All | 380 | Phase 3 | United States;Canada;Germany;Italy;Japan;Korea, Republic of;Switzerland |
| 9 | 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 | Active, not recruiting | 18 Years | N/A | All | 140 | Phase 3 | United States;Canada;France;Germany;Italy;Japan |
| 10 | 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 | ||
| 11 | 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 |
| 12 | 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 |