Laquinimod sodium (usan) (DrugBank: Laquinimod)
1 disease| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 29 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2014-001579-30-NL (EUCTR) | 21/05/2015 | 26/11/2014 | 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) ascompared to placebo | 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: 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Germany;Netherlands;Italy;United Kingdom | ||
| 2 | EUCTR2014-001579-30-DE (EUCTR) | 20/03/2015 | 11/11/2014 | 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) ascompared to placebo | 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: 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. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2014-001579-30-ES (EUCTR) | 22/12/2014 | 23/10/2014 | 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) ascompared to placebo | 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: 17.1;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. | NULL | Not Recruiting | Female: yes Male: yes | 375 | Phase 2 | United States;Canada;Poland;Spain;Ukraine;Russian Federation;Netherlands;Germany;Italy;United Kingdom | ||
| 4 | EUCTR2014-001579-30-IT (EUCTR) | 04/12/2014 | 19/09/2014 | 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) ascompared to placebo | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 375 | Phase 2 | Ukraine;Russian Federation;Netherlands;Germany;United Kingdom;Italy;United States;Canada;Spain | ||
| 5 | EUCTR2013-002082-19-NL (EUCTR) | 09/01/2014 | 17/10/2013 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2013-002082-19-ES (EUCTR) | 02/01/2014 | 31/10/2013 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 7 | EUCTR2013-002082-19-FI (EUCTR) | 04/12/2013 | 15/10/2013 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 8 | EUCTR2013-002082-19-DK (EUCTR) | 03/12/2013 | 03/12/2013 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| 9 | EUCTR2013-002082-19-BE (EUCTR) | 25/11/2013 | 13/09/2013 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 10 | EUCTR2013-002082-19-SE (EUCTR) | 21/11/2013 | 13/09/2013 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2013-002082-19-GB (EUCTR) | 13/11/2013 | 06/11/2013 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden | ||
| 12 | EUCTR2012-003647-30-AT (EUCTR) | 27/08/2013 | 07/02/2013 | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Serbia;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 | ||
| 13 | EUCTR2012-003647-30-CZ (EUCTR) | 08/07/2013 | 28/11/2012 | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;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 | ||
| 14 | EUCTR2012-003647-30-IT (EUCTR) | 24/05/2013 | 11/01/2013 | 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) | 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 LTD | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;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 | ||
| 15 | EUCTR2012-003647-30-PL (EUCTR) | 11/04/2013 | 12/02/2013 | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | EUCTR2012-003647-30-BE (EUCTR) | 18/01/2013 | 08/10/2012 | 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: 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | Belarus;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 | |||
| 17 | EUCTR2012-003647-30-HU (EUCTR) | 04/01/2013 | 25/10/2012 | 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: 19.0;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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;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 | ||
| 18 | EUCTR2012-003647-30-ES (EUCTR) | 04/01/2013 | 29/10/2012 | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;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 | ||
| 19 | EUCTR2012-003647-30-EE (EUCTR) | 03/01/2013 | 19/11/2012 | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;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 | ||
| 20 | EUCTR2012-003647-30-LV (EUCTR) | 13/12/2012 | 25/10/2012 | 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: 19.0;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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2199 | Phase 3 | Belarus;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 | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2012-003647-30-GR (EUCTR) | 11/12/2012 | 14/11/2012 | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Belarus;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 | ||
| 22 | EUCTR2012-003647-30-SK (EUCTR) | 04/12/2012 | 20/02/2014 | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 2100 | Phase 3 | Belarus;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 | ||
| 23 | EUCTR2007-005450-23-DE (EUCTR) | 29/12/2008 | 28/10/2008 | 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 design - BRAVO | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy | |||
| 24 | EUCTR2007-005450-23-LT (EUCTR) | 27/08/2008 | 07/05/2008 | 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 design - BRAVO | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 25 | EUCTR2007-005450-23-BG (EUCTR) | 29/05/2008 | 27/05/2008 | 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 design - BRAVO | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Estonia;Bulgaria;Spain;Italy;Lithuania | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2007-005450-23-CZ (EUCTR) | 14/04/2008 | 12/02/2008 | 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 design - BRAVO | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania | |||
| 27 | EUCTR2007-005450-23-SK (EUCTR) | 10/04/2008 | 30/04/2008 | 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 design - BRAVO | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Estonia;Slovakia;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 28 | EUCTR2007-005450-23-EE (EUCTR) | 28/03/2008 | 11/02/2008 | 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 design - BRAVO | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy | |||
| 29 | EUCTR2007-005450-23-ES (EUCTR) | 17/03/2008 | 29/01/2008 | Estudio 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 | Estudio 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania |