ABR-215062 sodium salt ( DrugBank: - )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 42 |
| 96 | Crohn disease | 5 |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,342 / Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
| 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 | EUCTR2009-012989-30-AT (EUCTR) | 25/11/2010 | 14/12/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 2 | EUCTR2009-015815-42-LT (EUCTR) | 11/10/2010 | 09/08/2010 | An 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 disease | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 3 | EUCTR2009-015815-42-CZ (EUCTR) | 12/07/2010 | 12/05/2010 | An 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 disease | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 4 | EUCTR2009-015815-42-PL (EUCTR) | 08/07/2010 | 17/05/2010 | An 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 disease | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 5 | EUCTR2009-015815-42-SK (EUCTR) | 06/07/2010 | 17/05/2010 | 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 - - | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1245 | Phase 3 | Czech Republic;Estonia;Slovakia;Poland;Spain;Lithuania;Bulgaria;Germany;Italy | ||
| 6 | EUCTR2009-015815-42-BG (EUCTR) | 18/05/2010 | 18/05/2010 | An 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 disease | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 7 | EUCTR2009-012989-30-BG (EUCTR) | 31/03/2010 | 19/04/2010 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 8 | EUCTR2009-015815-42-EE (EUCTR) | 12/03/2010 | 12/02/2010 | An 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 disease | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 714 | Phase 3 | United States;Estonia;Slovakia;Spain;Ukraine;Lithuania;Israel;Russian Federation;Italy;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Bulgaria;South Africa;Georgia;Germany | ||
| 9 | EUCTR2009-012989-30-SE (EUCTR) | 23/02/2010 | 01/02/2010 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 10 | EUCTR2009-012989-30-FR (EUCTR) | 18/01/2010 | 22/09/2009 | 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 - - | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 11 | EUCTR2009-012989-30-LT (EUCTR) | 30/12/2009 | 02/10/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 12 | EUCTR2009-012989-30-GB (EUCTR) | 17/11/2009 | 13/07/2009 | 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 Ltd | NULL | Not 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): no | Serbia;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 | ||
| 13 | EUCTR2009-012989-30-CZ (EUCTR) | 16/11/2009 | 10/09/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 14 | EUCTR2009-012989-30-ES (EUCTR) | 21/10/2009 | 05/08/2009 | 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. - - | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Netherlands;Germany;Sweden | ||
| 15 | EUCTR2009-012989-30-NL (EUCTR) | 02/10/2009 | 20/07/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 632 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 16 | EUCTR2009-012989-30-EE (EUCTR) | 11/09/2009 | 05/08/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 542 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 17 | EUCTR2009-012989-30-HU (EUCTR) | 09/09/2009 | 14/08/2009 | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 632 | Phase 3 | United States;Serbia;Estonia;Spain;Ukraine;Lithuania;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Georgia;Netherlands;Germany;Sweden | ||
| 18 | EUCTR2009-011234-99-DE (EUCTR) | 23/06/2009 | 21/04/2009 | 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) | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 1 | Germany | ||
| 19 | EUCTR2007-003226-19-BG (EUCTR) | 22/05/2008 | 22/03/2008 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1419 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 20 | EUCTR2007-003226-19-PT (EUCTR) | 01/02/2008 | 24/10/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 21 | EUCTR2007-003226-19-LT (EUCTR) | 11/01/2008 | 25/09/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 22 | EUCTR2007-003226-19-SE (EUCTR) | 27/12/2007 | 29/10/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Sweden;Lithuania;United Kingdom;Czech Republic;Estonia;Spain | |||
| 23 | EUCTR2007-003226-19-EE (EUCTR) | 04/12/2007 | 10/10/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 24 | EUCTR2007-003226-19-ES (EUCTR) | 22/11/2007 | 04/10/2007 | Estudio 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 | Estudio 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | ||
| 25 | EUCTR2007-003226-19-LV (EUCTR) | 06/11/2007 | 12/09/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 26 | EUCTR2007-003226-19-CZ (EUCTR) | 25/10/2007 | 10/09/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;Czech Republic;United Kingdom;Estonia;Spain | |||
| 27 | EUCTR2007-003226-19-GB (EUCTR) | 24/10/2007 | 01/08/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 28 | EUCTR2007-003226-19-DE (EUCTR) | 23/10/2007 | 15/07/2008 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Portugal;Estonia;Spain;Lithuania;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | |||
| 29 | EUCTR2007-003226-19-HU (EUCTR) | 09/10/2007 | 13/07/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 30 | EUCTR2007-003226-19-AT (EUCTR) | 30/09/2007 | 19/09/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 31 | EUCTR2007-003226-19-FR (EUCTR) | 21/09/2007 | 06/08/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Estonia;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Bulgaria;Germany;Netherlands;Latvia;Sweden | ||
| 32 | EUCTR2007-003226-19-NL (EUCTR) | 05/09/2007 | 12/07/2007 | Study 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 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1419 | Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Latvia;Austria;Lithuania;Sweden;United Kingdom;Czech Republic;Estonia;Spain | |||
| 33 | EUCTR2005-004334-41-CZ (EUCTR) | 13/02/2006 | 12/01/2006 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Hungary;Czech Republic;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 34 | EUCTR2005-004334-41-GB (EUCTR) | 10/02/2006 | 31/10/2005 | An 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 Ltd | NULL | Not 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): no | Hungary;Czech Republic;Poland;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 35 | EUCTR2005-004334-41-DE (EUCTR) | 11/01/2006 | 21/11/2005 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 36 | EUCTR2005-004334-41-ES (EUCTR) | 04/01/2006 | 10/11/2005 | An 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 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 310 | Phase 2 | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 37 | EUCTR2005-004334-41-HU (EUCTR) | 20/12/2005 | 04/11/2005 | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 115 | Phase 2 | Czech Republic;Hungary;Spain;Russian Federation;Israel;Germany;Italy;United Kingdom | ||
| 38 | EUCTR2004-003943-28-DE (EUCTR) | 06/04/2005 | 14/09/2005 | 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 | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
| 39 | EUCTR2004-003943-28-CZ (EUCTR) | 21/03/2005 | 09/02/2005 | 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 | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy | |||
| 40 | EUCTR2004-003943-28-GB (EUCTR) | 18/02/2005 | 22/02/2005 | 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 | 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 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 Ltd | NULL | Not 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): no | Czech Republic;Hungary;Spain;Germany;Italy;United Kingdom | ||
| 41 | EUCTR2004-003943-28-ES (EUCTR) | 17/02/2005 | 09/12/2005 | 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 | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 264 | Phase 2 | Czech Republic;Hungary;Spain;Germany;United Kingdom;Italy | ||
| 42 | EUCTR2004-003943-28-HU (EUCTR) | 14/02/2005 | 13/12/2004 | 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 | 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 265 | Hungary;Germany;United Kingdom;Czech Republic;Spain;Italy |
96. Crohn disease
Clinical trials : 2,400 / Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215
| 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 | EUCTR2008-004276-49-FR (EUCTR) | 18/12/2008 | 21/07/2008 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | France;Belgium;Spain;Netherlands;United Kingdom;Italy | ||
| 2 | EUCTR2008-004276-49-GB (EUCTR) | 12/11/2008 | 27/01/2009 | A 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 | A 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. | NULL | Not 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): no | France;Belgium;Spain;Netherlands;Italy;United Kingdom | ||
| 3 | EUCTR2008-004276-49-NL (EUCTR) | 14/10/2008 | 05/08/2008 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | United Kingdom;Netherlands;Belgium;France;Spain;Italy | ||
| 4 | EUCTR2008-004276-49-BE (EUCTR) | 07/10/2008 | 15/09/2008 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Spain;Belgium;Netherlands;United Kingdom;Italy | ||
| 5 | EUCTR2008-004276-49-ES (EUCTR) | 16/09/2008 | 18/07/2008 | 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. | 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. | NULL | Not Recruiting | Female: yes Male: yes | 199 | Phase 2 | France;Belgium;Spain;Netherlands;United Kingdom;Italy |