Masitinib 200mg ( 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2
5進行性核上性麻痺1

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001862-13-IE
(EUCTR)
04/08/2020Evaluation 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) - AB19001 ALS masitinib/placebo in combination with riluzole patients suffering from 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: Masitinib 100mg
Product Code: AB1010
INN or Proposed INN: Masitinib Mesylate
Product Name: Masitinib 200mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden
2EUCTR2019-001862-13-GB
(EUCTR)
24/03/2020Evaluation 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) - AB19001 ALS masitinib/placebo in combination with riluzole patients suffering from 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: Masitinib 100mg
Product Code: AB1010
INN or Proposed INN: Masitinib Mesylate
Other descriptive name: na
Product Name: Masitinib 200mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: na
AB ScienceNULLNAFemale: yes
Male: yes
495Phase 3United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden

5. 進行性核上性麻痺


臨床試験数 : 89 薬物数 : 107 - (DrugBank : 40) / 標的遺伝子数 : 65 - 標的パスウェイ数 : 108
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-003740-23-ES
(EUCTR)
04/02/201505/12/2013Evaluation of masitinib in the treatment of Progressive Supranuclear PalsyA prospective, multicentre, randomised, double-blind, placebo-controlled, parallel groups, phase 2b/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Progressive Supranuclear Palsy (PSP) Progressive Supranuclear Palsy
MedDRA version: 14.1;Level: PT;Classification code 10036813;Term: Progressive supranuclear palsy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: masitinib 100mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: MASITINIB MESYLATE
Product Name: masitinib 200mg
Product Code: AB1010
INN or Proposed INN: Masitinib mesylate
Other descriptive name: MASITINIB MESYLATE
AB ScienceNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain