Mt-1186 (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 2 | Amyotrophic lateral sclerosis | 5 |
| 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 | 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 |
| 2 | 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 |
| 3 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Canada;Germany;Japan;Italy | ||
| 4 | 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 |
| 5 | 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 |