Masitinib mesilate ( DrugBank: Masitinib )
2 diseases
| 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 | 1 |
| 13 | 多発性硬化症／視神経脊髄炎 | 3 |
2. 筋萎縮性側索硬化症
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 | EUCTR2019-001862-13-IT (EUCTR) | 03/02/2021 | 06/11/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - non applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 | AB SCIENCE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | EUCTR2021-000639-30-DE (EUCTR) | 16/12/2022 | 24/01/2022 | A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse. | A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, PlaceboControlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse | Patients with primary progressive or secondary progressive multiple sclerosis without relapse MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Russian Federation;Hungary;United States;Ukraine;United Kingdom;Portugal;Spain;Greece;Canada;Sweden;Norway;Finland;Poland;South Africa;Italy;Israel;France;Bulgaria;Germany | ||
| 2 | EUCTR2021-000639-30-GR (EUCTR) | 06/04/2022 | 04/02/2022 | A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse. | A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse. | Patients with primary progressive or secondary progressive multiple sclerosis without relapse MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Greece;Finland;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Bulgaria;South Africa;Germany;Sweden | ||
| 3 | EUCTR2021-000639-30-ES (EUCTR) | 12/01/2022 | 20/09/2021 | A phase 3 study to compare efficacy and safety of masitinib with placebo in the patients with primary progressive or secondary progressive multiple sclerosis without relapse. | A 96-Weeks, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/day versus Placebo in the Treatment of Patients with Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse. | Patients with primary progressive or secondary progressive multiple sclerosis without relapse MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesilate | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Canada;Poland;South Africa;Bulgaria;Germany;Sweden;Portugal;United States;Greece;Finland;Spain;Ukraine;Israel;Russian Federation;United Kingdom;Italy;France;Hungary |