2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 624 / 薬物数 : 611 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
| 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 | EUCTR2019-001862-13-PT (EUCTR) | 18/02/2022 | 21/05/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Greece;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2019-001862-13-GR (EUCTR) | 03/02/2022 | 26/11/2021 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - Amyotrophic Lateral Sclerosis (ALS) | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Greece;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2019-001862-13-DK (EUCTR) | 21/09/2021 | 30/06/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Sweden | ||
| 4 | EUCTR2019-001862-13-NO (EUCTR) | 03/02/2021 | 20/11/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | Portugal;United States;Slovenia;Spain;Ukraine;Ireland;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 5 | EUCTR2019-001862-13-IT (EUCTR) | 03/02/2021 | 06/11/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - non applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 Product Name: Masitinib mesilate Product Code: [AB1010] INN or Proposed INN: Masitinib mesilate Other descriptive name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-thiazolyl]amino]phenyl]-benzamide, methane sulphonic acid salt. AB1010base; AB 1003 | AB SCIENCE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2019-001862-13-PL (EUCTR) | 01/12/2020 | 09/07/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 7 | EUCTR2019-001862-13-SE (EUCTR) | 14/10/2020 | 23/03/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | Portugal;United States;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 8 | NCT03127267 (ClinicalTrials.gov) | October 1, 2020 | 13/4/2017 | Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients | A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Groups, Phase 3 Study to Compare the Efficacy and Safety of Masitinib in Combination With Riluzole Versus Placebo in Combination With Riluzole in the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis | Drug: Masitinib (6.0);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (4.5) | AB Science | NULL | Recruiting | 18 Years | 81 Years | All | 495 | Phase 3 | United States;Germany;Canada |
| 9 | EUCTR2019-001862-13-ES (EUCTR) | 15/09/2020 | 12/06/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 10 | EUCTR2019-001862-13-SI (EUCTR) | 12/03/2020 | 19/02/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ukraine;Ireland;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden | ||
| 11 | EUCTR2010-024423-24-NL (EUCTR) | 21/09/2015 | 09/09/2015 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 19.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 12 | EUCTR2010-024423-24-IT (EUCTR) | 05/05/2015 | 04/02/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | Studio prospettico, multicentrico, randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, di fase 2/3 sull'efficacia e la sicurezza di masitinib a confronto con placebo nel trattamento di pazienti affetti da Sclerosi Laterale Amiotrofica (SLA) - AB10015 | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 18.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Other descriptive name: MASITINIB MESYLATE INN or Proposed INN: Masitinib Mesylate Other descriptive name: MASITINIB MESYLATE | AB SCIENCE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 381 | Portugal;Serbia;Slovakia;Greece;Spain;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Argentina;Romania;Germany | |||
| 13 | EUCTR2010-024423-24-HU (EUCTR) | 21/04/2015 | 31/10/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ireland;Israel;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Romania;Germany;Netherlands | ||
| 14 | EUCTR2010-024423-24-PT (EUCTR) | 10/04/2015 | 03/11/2014 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 15 | EUCTR2010-024423-24-GR (EUCTR) | 06/03/2015 | 21/11/2013 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | Patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 17.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Argentina;Netherlands;Germany | ||
| 16 | EUCTR2010-024423-24-SK (EUCTR) | 07/04/2014 | 05/12/2013 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 20.0;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na INN or Proposed INN: Masitinib mesylate Other descriptive name: na | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Ireland;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Romania;Netherlands;Germany | ||
| 17 | NCT02588677 (ClinicalTrials.gov) | April 2013 | 20/10/2015 | Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS) | Multicenter, Randomised, Double-blind, Placebo-controlled, Parallel Group, Phase 2/3 Study to Compare the Efficacy and Safety of Masitinib | Amyotrophic Lateral Sclerosis (ALS) | Drug: Masitinib (4.5);Drug: Riluzole;Drug: Placebo;Drug: Masitinib (3.0) | AB Science | NULL | Completed | 18 Years | N/A | All | 394 | Phase 2/Phase 3 | Spain |
| 18 | EUCTR2010-024423-24-ES (EUCTR) | 29/01/2013 | 29/11/2012 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomized, double-blind, placebocontrolled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - not applicable | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na Product Name: masitinib Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: MASITINIB | ABScience | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Portugal;France;Hungary;Slovakia;Greece;Spain;Ireland;Netherlands;Italy | ||
| 19 | EUCTR2010-024423-24-IE (EUCTR) | 06/11/2014 | A controlled clinical study to investigate the effectiveness and safety of the medicine called masitinib when used together with a currently available medicine Riluzole when treating the illness called Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 Study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS). - IRELAND Phase 2/3 study comparing Masitinib/Placebo in ALS | Amyotrophic lateral Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100 mg Tablets Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: SUB126308 Product Name: Masitinib 200 mg Tablets Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: SUB126308 | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 381 | Phase 2;Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ireland;Colombia;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Argentina;Belgium;Romania;Netherlands;Germany | |||
| 20 | EUCTR2019-001862-13-IE (EUCTR) | 04/08/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100mg Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Product Name: Masitinib 200mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | Not Recruiting | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden | |||
| 21 | EUCTR2019-001862-13-GB (EUCTR) | 24/03/2020 | Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS) | A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB19001 ALS masitinib/placebo in combination with riluzole | patients suffering from Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Masitinib 100mg Product Code: AB1010 INN or Proposed INN: Masitinib Mesylate Other descriptive name: na Product Name: Masitinib 200mg Product Code: AB1010 INN or Proposed INN: Masitinib mesylate Other descriptive name: na | AB Science | NULL | NA | Female: yes Male: yes | 495 | Phase 3 | United States;Portugal;Slovenia;Spain;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Canada;Argentina;Belgium;Poland;Denmark;Germany;Netherlands;Sweden |