Laquinimod capsules 0.5 mg ( DrugBank: Laquinimod )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
8ハンチントン病7
96クローン病4

8. ハンチントン病


臨床試験数 : 242 薬物数 : 205 - (DrugBank : 62) / 標的遺伝子数 : 85 - 標的パスウェイ数 : 159
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-000418-75-NL
(EUCTR)
04/11/201515/10/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 18.1;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 2Portugal;United States;Czech Republic;Canada;Spain;Russian Federation;Germany;Netherlands;Italy;United Kingdom
2EUCTR2014-000418-75-GB
(EUCTR)
30/01/201524/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
3EUCTR2014-000418-75-DE
(EUCTR)
06/01/201525/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 2Portugal;United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
4EUCTR2014-000418-75-CZ
(EUCTR)
05/01/201525/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 19.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 2Portugal;United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
5EUCTR2014-000418-75-IT
(EUCTR)
18/11/201425/08/2014A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 17.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 2United States;Portugal;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
6EUCTR2014-000418-75-PT
(EUCTR)
31/10/201425/09/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 20.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Portugal;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom
7EUCTR2014-000418-75-ES
(EUCTR)
23/10/201416/10/2014A clinical study in subjects with Huntington's Disease to assess the efficacy and safety of three oral doses of laquinimod, either 0.5 mg/day, 1.0 mg/day or 1.5 mg/day (experimental drug)A Multicenter, Multinational, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Laquinimod (0.5, 1.0 and 1.5 mg/day) as Treatment in Patients with Huntington's Disease - LEGATO-HD (Laquinimod Efficacy and Safety in a GlobAl Trial Of HD) Huntington's Disease (HD)
MedDRA version: 17.0;Level: PT;Classification code 10070668;Term: Huntington's disease;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: 5-Chloro-1,2-dihydro-N-ethyl-4-hydroxy-1-methyl-2-oxo-N-phenyl-3-quinolinecarboxamide sodium
Teva Branded Pharmaceutical Products R&D, Inc.NULLNot RecruitingFemale: yes
Male: yes
400Phase 2Portugal;France;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-004276-49-FR
(EUCTR)
18/12/200821/07/2008A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
199Phase 2France;Belgium;Spain;Netherlands;United Kingdom;Italy
2EUCTR2008-004276-49-GB
(EUCTR)
12/11/200827/01/2009A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Spain;Netherlands;Italy;United Kingdom
3EUCTR2008-004276-49-NL
(EUCTR)
14/10/200805/08/2008A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
199Phase 2United Kingdom;Netherlands;Belgium;France;Spain;Italy
4EUCTR2008-004276-49-BE
(EUCTR)
07/10/200815/09/2008A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s DiseaseA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn’s Disease Moderate to severe Crohn's disease (CD)
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Capsules 0.5 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Spain;Belgium;Netherlands;United Kingdom;Italy