2. 筋萎縮性側索硬化症 Amyotrophic lateral sclerosis Clinical trials / Disease details
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 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 | EUCTR2020-003376-40-SE (EUCTR) | 23/02/2022 | 29/12/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 2 | EUCTR2020-003376-40-DE (EUCTR) | 26/10/2021 | 16/06/2021 | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | NCT05178810 (ClinicalTrials.gov) | October 18, 2021 | 16/12/2021 | Study to Investigate the Efficacy and Safety of FAB122 (Daily Oral Edaravone) in Patients With Amyotrophic Lateral Sclerosis | A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis | Drug: FAB122;Drug: Placebo | Ferrer Internacional S.A. | Julius Clinical;Stichting TRICALS Foundation | Active, not recruiting | 18 Years | 80 Years | All | 300 | Phase 3 | Belgium;France;Germany;Ireland;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom |
| 4 | EUCTR2020-003376-40-IE (EUCTR) | 12/10/2021 | 10/06/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2020-003376-40-ES (EUCTR) | 05/10/2021 | 23/06/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - ADORE (ALS Deceleration with ORal Edaravone) study | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Poland;Belgium;Spain;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy | ||
| 6 | EUCTR2020-003376-40-IT (EUCTR) | 28/09/2021 | 19/10/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis - - | Amyotrophic Lateral Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Edaravone Product Code: [FAB122] INN or Proposed INN: Edaravone Other descriptive name: Norphenazone; methylphenylpyrazolone; norantipyrine; 3-methyl-1-phenyl-4, 5-dihydro-1H-pyrazol-5-one. | Ferrer Internacional S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2020-003376-40-PL (EUCTR) | 18/08/2021 | 09/07/2021 | A study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;France;Spain;Belgium;Poland;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 8 | EUCTR2020-003376-40-BE (EUCTR) | 10/08/2021 | 08/06/2021 | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | A multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of FAB122 in patients with Amyotrophic Lateral Sclerosis | Amyotrophic Lateral Sclerosis 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: Edaravone Product Code: FAB122 INN or Proposed INN: EDARAVONE | Ferrer Internacional, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | France;Portugal;Spain;Poland;Belgium;Ireland;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden |