Laquinimod ( DrugBank: Laquinimod )


4 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8
13多発性硬化症/視神経脊髄炎89
49全身性エリテマトーデス2
96クローン病7

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
7NCT02215616
(ClinicalTrials.gov)
October 28, 201412/8/2014A Clinical Study in Participants With Huntington's Disease (HD) to Assess Efficacy and Safety of Three Oral Doses of LaquinimodA 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 DiseaseHuntington's DiseaseDrug: Laquinimod;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted21 Years55 YearsAll352Phase 2United States;Canada;Czechia;Germany;Italy;Netherlands;Portugal;Russian Federation;Spain;United Kingdom;Czech Republic;France;India;Israel
8EUCTR2014-000418-75-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

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001579-30-NL
(EUCTR)
21/05/201526/11/2014A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placeboA Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO Primary Progressive Multiple Sclerosis
MedDRA version: 18.1;Level: PT;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: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Canada;Spain;Poland;Ukraine;Russian Federation;Germany;Netherlands;United Kingdom;Italy
2EUCTR2014-001579-30-DE
(EUCTR)
20/03/201511/11/2014A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placeboA Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO Primary Progressive Multiple Sclerosis
MedDRA version: 20.0;Level: PT;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: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom
3NCT02284568
(ClinicalTrials.gov)
January 12, 201531/10/2014A Phase 2 Clinical Study in Subjects With Primary Progressive Multiple Sclerosis to Assess the Efficacy, Safety and Tolerability of Two Oral Doses of Laquinimod Either of 0.6 mg/Day or 1.5mg/Day (Experimental Drug) as Compared to PlaceboA Multinational, Multicenter, Randomized, Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisDrug: Placebo;Drug: LaquinimodTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted25 Years55 YearsAll374Phase 2United States;Canada;Germany;Italy;Netherlands;Poland;Russian Federation;Spain;Ukraine;United Kingdom
4EUCTR2014-001579-30-ES
(EUCTR)
22/12/201423/10/2014A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) ascompared to placeboA Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO Primary Progressive Multiple Sclerosis
MedDRA version: 17.1;Level: PT;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: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom
5EUCTR2014-001579-30-IT
(EUCTR)
04/12/201419/09/2014A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO Primary Progressive Multiple Sclerosis
MedDRA version: 17.0;Level: PT;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: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
375Phase 2United States;Canada;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy
6EUCTR2014-001579-30-GB
(EUCTR)
27/11/201408/09/2014 A Phase 2 clinical study in subjects with Progressive Multiple Sclerosis to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.5mg/day (experimental drug) as compared to placeboA Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Oral Administration of Laquinimod (0.6 or 1.5 mg) in Patients with Primary Progressive Multiple Sclerosis (PPMS) - ARPEGGIO Primary Progressive Multiple Sclerosis
MedDRA version: 19.0;Level: PT;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: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries Ltd.NULLNot Recruiting Female: yes
Male: yes
375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom
7EUCTR2013-002082-19-NL
(EUCTR)
09/01/201417/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
8EUCTR2013-002082-19-ES
(EUCTR)
02/01/201431/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon beta-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon beta-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
9NCT01975298
(ClinicalTrials.gov)
January 201428/10/2013A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).Relapsing Remitting Multiple SclerosisDrug: Laquinimod;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLWithdrawn18 Years55 YearsAll0Phase 3Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
10EUCTR2013-002082-19-FI
(EUCTR)
04/12/201315/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
11EUCTR2013-002082-19-DK
(EUCTR)
03/12/201303/12/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
12EUCTR2013-002082-19-BE
(EUCTR)
25/11/201313/09/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
13EUCTR2013-002082-19-SE
(EUCTR)
21/11/201313/09/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
14EUCTR2013-002082-19-GB
(EUCTR)
13/11/201306/11/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden
15EUCTR2012-003647-30-AT
(EUCTR)
27/08/201307/02/2013A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
16EUCTR2012-003647-30-CZ
(EUCTR)
08/07/201328/11/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
17EUCTR2012-003647-30-IT
(EUCTR)
24/05/201311/01/2013A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS)A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - Concerto Relapsing remitting multiple sclerosis (RRMS).
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
Other descriptive name: Laquinimod Sodium (USAN)
TEVA PHARMACEUTICALS INDUSTRIES LTDNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany
18EUCTR2012-003647-30-PL
(EUCTR)
11/04/201312/02/2013A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;Estonia
19NCT01707992
(ClinicalTrials.gov)
February 20, 201328/9/2012The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Laquinimod;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll2199Phase 3United States;Austria;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Montenegro;North Macedonia;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Ukraine;United Kingdom;Czech Republic;Kazakhstan;Macedonia, The Former Yugoslav Republic of;Mexico;Portugal
20EUCTR2012-003647-30-BE
(EUCTR)
18/01/201308/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Belarus;Serbia;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany
21EUCTR2012-003647-30-ES
(EUCTR)
04/01/201329/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Israel;Italy;Puerto Rico;Macedonia, the former Yugoslav Republic of;Albania;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Croatia;Kazakhstan;Bulgaria;Georgia;Germany
22EUCTR2012-003647-30-HU
(EUCTR)
04/01/201325/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
23EUCTR2012-003647-30-EE
(EUCTR)
03/01/201319/11/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
24EUCTR2012-003647-30-GB
(EUCTR)
20/12/201223/10/2012 A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) consisting of two parts: First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
2199 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
25EUCTR2012-003647-30-LV
(EUCTR)
13/12/201225/10/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2199Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
26EUCTR2012-003647-30-GR
(EUCTR)
11/12/201214/11/2012A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3Belarus;United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Macedonia, the former Yugoslav Republic of;Albania;Latvia;Moldova, Republic of;Korea, Republic of;Bosnia and Herzegovina;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany
27EUCTR2012-003647-30-SK
(EUCTR)
04/12/201220/02/2014A clinical study in subjects with relapsing-remitting multiple sclerosis(RRMS) consisting of two parts:First part is to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared placebo. Second part (all subjects receiving active treatment) is to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6 mg/day or 1.2 mg/day (experimental drug).A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment period, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod (0.6 mg/day or 1.2 mg/day) in subjects with relapsing remitting multiple sclerosis (RRMS) - CONCERTO Relapsing remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
2100Phase 3Belarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Korea, Democratic People's Republic of;Austria;Montenegro;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
28NCT01404117
(ClinicalTrials.gov)
March 201226/7/2011A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and TolerabilityRelapsing Multiple SclerosisDrug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ PlaceboTeva Pharmaceutical IndustriesNULLWithdrawn18 Years55 YearsBoth0Phase 2NULL
29EUCTR2009-012989-30-AT
(EUCTR)
25/11/201014/12/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
30EUCTR2009-015815-42-LT
(EUCTR)
11/10/201009/08/2010An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the diseaseA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
714Phase 3United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany
31EUCTR2009-015815-42-CZ
(EUCTR)
12/07/201012/05/2010An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the diseaseA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
714Phase 3United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany
32EUCTR2009-015815-42-PL
(EUCTR)
08/07/201017/05/2010An extended clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-302 (BRAVO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the diseaseA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
714Phase 3United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany
33EUCTR2009-015815-42-SK
(EUCTR)
06/07/201017/05/2010A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - -A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1245Phase 3Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
34NCT01047319
(ClinicalTrials.gov)
May 27, 20108/1/2010A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple SclerosisA Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-302 (BRAVO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: LaquinimodTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminatedN/AN/AAll1047Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Macedonia, The Former Yugoslav Republic of;Puerto Rico
35EUCTR2009-015815-42-BG
(EUCTR)
18/05/201018/05/2010An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the diseaseA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
714Phase 3United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany
36EUCTR2009-012989-30-BG
(EUCTR)
31/03/201019/04/2010A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
37EUCTR2009-015815-42-IT
(EUCTR)
15/03/201001/03/2010A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - NDA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1245Phase 3Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
38EUCTR2009-015815-42-EE
(EUCTR)
12/03/201012/02/2010An extended clinical study in subjects with multiple sclerosis whosuccessfully completed the MS-LAQ-302 (BRAVO) study, to assess thesafety of laquinimod (experimental drug) when taken for a long period oftime and how it affects the course of the diseaseA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-302 (BRAVO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
714Phase 3United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany
39EUCTR2009-012989-30-SE
(EUCTR)
23/02/201001/02/2010A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
40EUCTR2009-012989-30-FR
(EUCTR)
18/01/201022/09/2009A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - -A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden
41EUCTR2009-012989-30-LT
(EUCTR)
30/12/200902/10/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
42EUCTR2009-012989-30-GB
(EUCTR)
17/11/200913/07/2009 A clinical study in subjects with multiple sclerosis who successfully completed the MS-LAQ-301 (ALLEGRO) study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
542 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Estonia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Romania;Bulgaria;Georgia;Netherlands;Germany;Sweden
43EUCTR2009-012989-30-CZ
(EUCTR)
16/11/200910/09/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden
44NCT00988052
(ClinicalTrials.gov)
November 10, 200928/9/2009A Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MSA Multinational, Multicenter, Open-label, Single-assignment Extension of the MS-LAQ-301 (ALLEGRO) Study, to Evaluate the Long-term Safety, Tolerability and Effect on Disease Course of Daily Oral Laquinimod 0.6 mg in Subjects With Relapsing MSRelapsing Multiple SclerosisDrug: LaquinimodTeva Branded Pharmaceutical Products R&D, Inc.NULLTerminated18 Years55 YearsAll839Phase 3United States;Austria;Bulgaria;Canada;Czechia;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;Latvia
45EUCTR2009-012989-30-ES
(EUCTR)
21/10/200905/08/2009Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - -Extensión multinacional, multicéntrica y de fase abierta con tratamiento activo del estudio MS-LAQ-301 (Allegro) para evaluar la seguridad a largo plazo, la tolerabilidad y el efecto sobre el curso de la enfermedad de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple recurrente. - - Esclerosis Múltiple Remitente Recurrente (RRMS).
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsulas 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden
46EUCTR2009-012989-30-IT
(EUCTR)
06/10/200911/09/2009A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - NDA multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - ND Relapsing - Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod
INN or Proposed INN: Laquinimod
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden
47EUCTR2009-012989-30-NL
(EUCTR)
02/10/200920/07/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
632Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden
48EUCTR2009-012989-30-EE
(EUCTR)
11/09/200905/08/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
542Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden
49EUCTR2009-012989-30-HU
(EUCTR)
09/09/200914/08/2009A clinical study in subjects with multiple sclerosis who successfullycompleted the MS-LAQ-301 (ALLEGRO) study, to assess the safety oflaquinimod (experimental drug) when taken for a long period of time andhow it affects the course of the disease.A multinational, multicenter, open-label, single-assignment extension of the MS-LAQ-301 (ALLEGRO) study, to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis - - Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis.
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
632Phase 3United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden
50EUCTR2009-011234-99-DE
(EUCTR)
23/06/200921/04/2009A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administereddaily in subjects with relapsing remitting multiple sclerosis (RRMS)A Phase I, sequential group, randomized, double-blind, placebo-controlled study to assess the tolerability and safety of escalating doses of oral laquinimod administereddaily in subjects with relapsing remitting multiple sclerosis (RRMS) - MS-LAQ-101 Laquinimod is developed for the treatment of relapsing remitting multiple sclerosis (RRMS).This study is planned to assess the tolerability and safety of escalating doses of orallaquinimod administered daily in subjects with RRMS.
MedDRA version: 15.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Product Name: Laquinimod Capsules 0.3 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
160Phase 1Germany
51EUCTR2007-005450-23-DE
(EUCTR)
29/12/200828/10/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
INN or Proposed INN: INTERFERON BETA-1A
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy
52EUCTR2007-005450-23-LT
(EUCTR)
27/08/200807/05/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A (Avonex®)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
53EUCTR2007-005450-23-BG
(EUCTR)
29/05/200827/05/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Estonia;Bulgaria;Spain;Italy;Lithuania
54EUCTR2007-003226-19-BG
(EUCTR)
22/05/200822/03/2008Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1419Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
55NCT00605215
(ClinicalTrials.gov)
April 24, 20088/1/2008BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded DesignMultiple SclerosisDrug: Laquinimod;Drug: Placebo;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll1331Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Latvia;Macedonia, The Former Yugoslav Republic of;Montenegro;Turkey
56EUCTR2007-005450-23-CZ
(EUCTR)
14/04/200812/02/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
57EUCTR2007-005450-23-SK
(EUCTR)
10/04/200830/04/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Czech Republic;Estonia;Slovakia;Spain;Lithuania;Bulgaria;Germany;Italy
58EUCTR2007-005450-23-EE
(EUCTR)
28/03/200811/02/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Product Name: -
Product Code: -
INN or Proposed INN: interferon beta-1a
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy
59EUCTR2007-005450-23-ES
(EUCTR)
17/03/200829/01/2008Estudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVOEstudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVO Esclerosis Múltiple Remitente Recurrente (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Cápsulas de Laquinimod 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgramos/0.5 ml Solución para inyección
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
60EUCTR2007-005450-23-IT
(EUCTR)
04/03/200813/03/2008A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon β-1a (Avonex) in a rater-blinded design - BravoA multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon β-1a (Avonex) in a rater-blinded design - Bravo Multiple sclerosis with relapse
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: laquinimod
Product Code: TV-5600
INN or Proposed INN: laquinimod
Trade Name: AVONEX*IM 4SIR 30MCG/0,5ML+4AG
INN or Proposed INN: Interferon beta-1a
TEVA ITALIA srlNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
61EUCTR2007-003226-19-PT
(EUCTR)
01/02/200824/10/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
62EUCTR2007-003226-19-LT
(EUCTR)
11/01/200825/09/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
63EUCTR2007-003226-19-SE
(EUCTR)
27/12/200729/10/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Sweden;Lithuania;United Kingdom;Czech Republic;Estonia;Spain
64EUCTR2007-003226-19-IT
(EUCTR)
06/12/200710/03/2008A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - AllegroA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS). - Allegro Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: laquinimod
Product Code: TV-5600
INN or Proposed INN: laquinimod
TEVA ITALIA srlNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
65EUCTR2007-003226-19-EE
(EUCTR)
04/12/200710/10/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
66NCT00509145
(ClinicalTrials.gov)
December 200727/7/2007Safety and Efficacy of Orally Administered Laquinimod Versus Placebo for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study, to Evaluate the Safety, Tolerability and Efficacy of Daily Oral Administration of Laquinimod 0.6 mg in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Laquinimod;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted18 Years55 YearsBoth1106Phase 3United States;Austria;Bulgaria;Canada;Czech Republic;Estonia;France;Georgia;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;Former Serbia and Montenegro;Spain;Sweden;Turkey;Ukraine;United Kingdom;Portugal
67EUCTR2007-003226-19-ES
(EUCTR)
22/11/200704/10/2007Estudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - AllegroEstudio multinacional, multicéntrico, randomizado, doble ciego, de grupos paralelos, controlado con placebo, para evaluar la seguridad, tolerabilidad y eficacia de la administración oral de laquinimod 0,6mg una vez al día en pacientes con esclerosis múltiple remitente recurrente (RRMS). - Allegro Esclerosis Múltiple Remitente Recurrente (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden
68EUCTR2007-003226-19-LV
(EUCTR)
06/11/200712/09/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
69EUCTR2007-003226-19-CZ
(EUCTR)
25/10/200710/09/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;Czech Republic;United Kingdom;Estonia;Spain
70EUCTR2007-003226-19-GB
(EUCTR)
24/10/200701/08/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
71EUCTR2007-003226-19-DE
(EUCTR)
23/10/200715/07/2008Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Portugal;Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden
72EUCTR2007-003226-19-HU
(EUCTR)
09/10/200713/07/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
73EUCTR2007-003226-19-AT
(EUCTR)
30/09/200719/09/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
74EUCTR2007-003226-19-FR
(EUCTR)
21/09/200706/08/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden
75EUCTR2007-003226-19-NL
(EUCTR)
05/09/200712/07/2007Study Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - AllegroStudy Title: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS) - Allegro Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1419Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain
76EUCTR2005-004334-41-CZ
(EUCTR)
13/02/200612/01/2006An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Hungary;Czech Republic;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom
77EUCTR2005-004334-41-GB
(EUCTR)
10/02/200631/10/2005An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
105 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Poland;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom
78EUCTR2005-004334-41-DE
(EUCTR)
11/01/200621/11/2005An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom
79EUCTR2005-004334-41-ES
(EUCTR)
04/01/200610/11/2005An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsAn active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the efficacy, tolerability and safety of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
310Phase 2Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom
80EUCTR2005-004334-41-HU
(EUCTR)
20/12/200504/11/2005An extended clinical study in subjects with multiple sclerosis who successfully completed the LAQ/5062 and LAQ/5063 study, to assess the safety of laquinimod (experimental drug) when taken for a long period of time and how it affects the course of the disease.An active extension of LAQ/5062 study. A multinational, multicenter, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3 mg and 0.6 mg) of laquinimod, orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: ABR-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
115Phase 2Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom
81NCT00745615
(ClinicalTrials.gov)
December 7, 20052/9/2008An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the DiseaseAn Active Extension of LAQ/5062 Study. A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses (0.3 mg and 0.6 mg) of Laquinimod, Orally Administered in Relapsing Remitting (R-R) Multiple Sclerosis (MS) Subjects (Study LAQ/5063 Active Double-Blind Phase) Followed by an Open Label Phase of Laquinimod 0.6 mg Daily (LAQ/5063 OL)Relapsing Remitting Multiple SclerosisDrug: Laquinimod;Drug: PlaceboTeva Pharmaceutical Industries, Ltd.NULLTerminated18 Years50 YearsAll257Phase 2Czechia;Germany;Hungary;Israel;Italy;Poland;Russian Federation;Spain;United Kingdom;Czech Republic
82EUCTR2005-004334-41-IT
(EUCTR)
30/11/200501/03/2006An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL).An active extension of LAQ/5062 study. A multinational, multi-center, randomized, double-blind, parallel-group study, to evaluate the safety, tolerability and efficacy of two doses (0.3mg and 0.6mg) of laquinimod, orally administered in relapsing remitting (R-R) Multiple Sclerosis (MS) subjects (study LAQ/5063 active double-blind phase) followed by an open label phase of laquinimod 0.6 mg daily (LAQ/5063 OL). Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Laquinimod
Product Code: ABR-215062
INN or Proposed INN: LAQUINIMOD
Teva Pharmaceutical Industries LdtNULLNot RecruitingFemale: yes
Male: yes
246Phase 2Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy
83EUCTR2004-003943-28-DE
(EUCTR)
06/04/200514/09/2005A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
264Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
84EUCTR2004-003943-28-CZ
(EUCTR)
21/03/200509/02/2005A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
264Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy
85NCT00349193
(ClinicalTrials.gov)
March 200526/6/2006A Study to Evaluate the Effectiveness, Tolerability and Safety of LaquinimodA Multinational, Multicenter Randomized Double-Blind, Parallel-Group, Placebo-Controlled Study, to Evaluate the Efficacy, Tolerability and Safety of Two Doses of, Oral Laquinimod in Relapsing Remitting (R-R) Multiple Sclerosis (MS) SubjectsRelapsing Remitting Multiple SclerosisDrug: laquinimod 0.3;Drug: laquinimod 0.6;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted18 Years50 YearsBoth306Phase 2Italy
86EUCTR2004-003943-28-GB
(EUCTR)
18/02/200522/02/2005A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
264 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Hungary;Spain;Germany;Italy;United Kingdom
87EUCTR2004-003943-28-ES
(EUCTR)
17/02/200509/12/2005A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
264Phase 2Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy
88EUCTR2004-003943-28-HU
(EUCTR)
14/02/200513/12/2004A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjectsA multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R) multiple sclerosis (MS) subjects Relapsing Remitting Multiple Sclerosis
MedDRA version: 5.1;Level: PT;Classification code 10028245
Product Name: Laquinimod Tablets 0.3 mg
Product Code: ABR-215062 sodium salt
INN or Proposed INN: laquinimod
Other descriptive name: PNU-215062 sodium salt
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
265Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy
89EUCTR2004-003943-28-IT
(EUCTR)
19/01/200502/02/2005A multinational,multicenter,randomized,double-blind,parallel-group,placebo-controlled study,to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R)multiple sclerosis (MS) subjects.A multinational,multicenter,randomized,double-blind,parallel-group,placebo-controlled study,to evaluate the efficacy, tolerability and safety of two doses of laquinimod orally administered in relapsing remitting (R-R)multiple sclerosis (MS) subjects. relapsing remitting multiple sclerosis subjects with an active lesion on MRI
MedDRA version: 6.1;Level: PT;Classification code 10048393
Trade Name: CITOCHINE ED IMMUNOMODULATORI
Product Name: LAQUINIMOD
Product Code: ABR-215062
INN or Proposed INN: LAQUINIMOD
TEVANULLNot RecruitingFemale: yes
Male: yes
Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01085084
(ClinicalTrials.gov)
October 4, 20109/3/2010A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus ArthritisA Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus ArthritisLupus ArthritisDrug: Laquinimod;Drug: PlaceboTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years75 YearsAll82Phase 2United States;Canada
2NCT01085097
(ClinicalTrials.gov)
September 1, 20104/3/2010A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus NephritisA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)Lupus NephritisDrug: Laquinimod;Drug: Mycophenolate Mofetil;Drug: Prednisolone/Prednisone;Drug: Placebo;Drug: MethylprednisoloneTeva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years75 YearsAll46Phase 2United States;Canada;France;Russian Federation;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
1NCT00737932
(ClinicalTrials.gov)
May 201018/8/2008Laquinimod Phase IIa Study in Active 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.Crohn's DiseaseDrug: Laquinimod;Other: placeboTeva Pharmaceutical IndustriesNULLCompleted18 Years75 YearsBoth180Phase 2Belgium;France;Israel;Italy;Netherlands;Poland;South Africa;Spain;United Kingdom
2EUCTR2008-004276-49-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
3EUCTR2008-004276-49-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
4EUCTR2008-004276-49-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
5EUCTR2008-004276-49-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
6EUCTR2008-004276-49-ES
(EUCTR)
16/09/200818/07/2008Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave.Estudio de fase IIa, multicéntrico, randomizado, doble ciego, controlado con placebo, de cohortes secuenciales, de búsqueda de rango de dosis para evaluar la seguridad, tolerabilidad y el efecto clínico de escalada de dosis de laquinimod en la Enfermedad de Crohn activa de moderada a grave. Enfermedad de Crohn activa de moderada a grave
MedDRA version: 9.1;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Laquinimod Cápsulas 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
7EUCTR2008-004276-49-IT
(EUCTR)
08/09/200804/08/2008A 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 Disease - NDA 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 - ND Crohn Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10013099;Term: Disease Crohns
Product Name: Laquinimod
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Teva Pharmaceutical Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United Kingdom;Netherlands;Belgium;France;Spain;Italy