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 | EUCTR2019-004619-30-IE (EUCTR) | 14/09/2020 | 03/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 2 | EUCTR2019-004619-30-DK (EUCTR) | 12/08/2020 | 03/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | France;Canada;Belgium;Poland;Denmark;Australia;Germany;Netherlands;Japan;Sweden;United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy | ||
| 3 | EUCTR2019-004619-30-DE (EUCTR) | 07/08/2020 | 11/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 4 | EUCTR2019-004619-30-IT (EUCTR) | 03/07/2020 | 17/01/2022 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: [ALXN1210] INN or Proposed INN: RAVULIZUMAB Other descriptive name: RAVULIZUMAB | ALEXION PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 5 | EUCTR2019-004619-30-SE (EUCTR) | 22/06/2020 | 04/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Japan;Sweden | ||
| 6 | EUCTR2019-004619-30-GB (EUCTR) | 26/05/2020 | 07/02/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: Ultomiris Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;Switzerland;United Kingdom;Italy;France;Canada;Poland;Korea, Republic of;Sweden;Japan;Netherlands;Germany;Denmark;Australia;Belgium | ||
| 7 | EUCTR2019-004619-30-FR (EUCTR) | 20/05/2020 | 20/08/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 8 | EUCTR2019-004619-30-ES (EUCTR) | 14/05/2020 | 06/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;Japan;Sweden;Korea, Republic of | ||
| 9 | EUCTR2019-004619-30-NL (EUCTR) | 23/04/2020 | 09/03/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Patients | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) - An Efficacy and Safety Study of Ravulizumab in ALS Patients | Amyotrophic Lateral Sclerosis (ALS), motor neuron disease MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Ultomiris Product Name: ravulizumab Product Code: ALXN1210 INN or Proposed INN: RAVULIZUMAB | Alexion Pharmaceuticals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 354 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 10 | NCT04248465 (ClinicalTrials.gov) | March 30, 2020 | 27/1/2020 | An Efficacy and Safety Study of Ravulizumab in ALS Participants | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis;ALS | Drug: Placebo;Biological: Ravulizumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 382 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Japan;Netherlands;Poland;Spain;Sweden;Switzerland;United Kingdom |