113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details
臨床試験数 : 622 / 薬物数 : 485 - (DrugBank : 99) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 168
| 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 | EUCTR2018-004009-22-CZ (EUCTR) | 25/09/2019 | 26/06/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients with Duchenne Muscular Dystrophy | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | Not Recruiting | Female: no Male: yes | 150 | Phase 2;Phase 3 | United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 2 | NCT03907072 (ClinicalTrials.gov) | September 4, 2019 | 5/4/2019 | Efficacy and Safety Study of WVE-210201 (Suvodirsen) With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy (DYSTANCE 51) | Duchenne Muscular Dystrophy | Drug: WVE-210201 (suvodirsen);Drug: Placebo | Wave Life Sciences Ltd. | NULL | Terminated | 5 Years | 12 Years | Male | 6 | Phase 2/Phase 3 | United States;Belgium;Canada;Czechia;France;Italy;Sweden;United Kingdom |
| 3 | EUCTR2018-004009-22-SE (EUCTR) | 20/07/2019 | 05/04/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | Not Recruiting | Female: no Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden | ||
| 4 | EUCTR2018-004009-22-IT (EUCTR) | 09/07/2019 | 05/11/2020 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients with Duchenne Muscular Dystrophy - - | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: [WVE-210201] Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | Not Recruiting | Female: no Male: yes | 150 | Phase 2;Phase 3 | United States;Czechia;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 5 | EUCTR2018-004009-22-GB (EUCTR) | 27/06/2019 | 28/03/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | Not Recruiting | Female: no Male: yes | 150 | Phase 2;Phase 3 | United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden | ||
| 6 | EUCTR2018-004009-22-BE (EUCTR) | 07/06/2019 | 21/05/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | Not Recruiting | Female: no Male: yes | 150 | Phase 2;Phase 3 | United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Japan;Sweden | ||
| 7 | EUCTR2018-000975-34-NL (EUCTR) | 06/02/2019 | 16/08/2018 | A Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001 | A Multicenter, Open-Label Extension Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001 | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 40 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Netherlands;Italy;United Kingdom | ||
| 8 | EUCTR2018-000975-34-BE (EUCTR) | 13/11/2018 | 21/09/2018 | A Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001 | A Multicenter, Open-Label Extension Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001 | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | Not Recruiting | Female: no Male: yes | 40 | Phase 1 | France;United States;Canada;Belgium;Netherlands;Italy;United Kingdom | ||
| 9 | EUCTR2018-000975-34-GB (EUCTR) | 25/10/2018 | 26/06/2018 | A Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001 | A Multicenter, Open-Label Extension Study of WVE-210201 in Patients Previously Enrolled in WVE-DMDX51-001 | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | Not Recruiting | Female: no Male: yes | 40 | Phase 1 | France;United States;Canada;Belgium;Netherlands;Italy;United Kingdom | ||
| 10 | EUCTR2017-002686-21-NL (EUCTR) | 26/06/2018 | 19/06/2018 | A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular Dystrophy | A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | Not Recruiting | Female: no Male: yes | 32 | Phase 1 | France;United States;Czech Republic;Belgium;Spain;Ireland;Denmark;Netherlands;Italy;United Kingdom | ||
| 11 | EUCTR2017-002686-21-BE (EUCTR) | 28/05/2018 | 12/03/2018 | A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular Dystrophy | A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | Not Recruiting | Female: no Male: yes | 32 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Netherlands;Italy;United Kingdom | ||
| 12 | EUCTR2017-002686-21-IT (EUCTR) | 25/05/2018 | 05/11/2020 | A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular Dystrophy | A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients with Duchenne Muscular Dystrophy - - | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: [WVE-210201] INN or Proposed INN: WVE-210201 | WAVE LIFE SCIENCES USA INC | NULL | Not Recruiting | Female: no Male: yes | 32 | Phase 1 | United States;France;Canada;Belgium;Netherlands;United Kingdom;Italy | ||
| 13 | EUCTR2017-002686-21-GB (EUCTR) | 11/04/2018 | 27/12/2017 | A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular Dystrophy | A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 32 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Netherlands;Italy;United Kingdom | ||
| 14 | NCT03508947 (ClinicalTrials.gov) | January 24, 2018 | 16/4/2018 | Safety and Tolerability of WVE-210201 in Patients With Duchenne Muscular Dystrophy | A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients With Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy | Drug: WVE-210201;Drug: Placebo | Wave Life Sciences Ltd. | NULL | Completed | 5 Years | 18 Years | Male | 36 | Phase 1 | United States;Belgium;Canada;France;Italy;Netherlands;United Kingdom |
| 15 | EUCTR2017-002686-21-FR (EUCTR) | 29/01/2018 | A study to assess the safety and tolerability of different doses of WVE-210201 in patients with Duchenne Muscular Dystrophy | A Multicenter, Double-blind, Placebo-controlled, Phase 1 Study of WVE-210201 Administered Intravenously to Patients with Duchenne Muscular Dystrophy | Duchenne Muscular Dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | Not Recruiting | Female: no Male: yes | 32 | Phase 1 | United States;France;Czech Republic;Belgium;Spain;Ireland;Denmark;Netherlands;Italy;United Kingdom | |||
| 16 | EUCTR2018-004009-22-PL (EUCTR) | 18/06/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients with Duchenne Muscular Dystrophy | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | Not Recruiting | Female: no Male: yes | 150 | Phase 2;Phase 3 | United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan;Sweden;Turkey;Ireland;Spain;United States | |||
| 17 | EUCTR2018-004009-22-NL (EUCTR) | 13/05/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients with Duchenne Muscular Dystrophy | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | NA | Female: no Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 18 | EUCTR2018-000975-34-FR (EUCTR) | 28/06/2018 | A Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001 | A Multicenter, Open-Label Extension Study of WVE-210201 in Patients previously enrolled in WVE-DMDX51-001 | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 | Wave Life Sciences Ltd. | NULL | NA | Female: no Male: yes | 40 | Phase 1 | United States;France;Canada;Belgium;Netherlands;Italy;United Kingdom | |||
| 19 | EUCTR2018-004009-22-FR (EUCTR) | 26/03/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 in Ambulatory Patients with Duchenne Muscular Dystrophy | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | NA | Female: no Male: yes | 150 | Phase 2;Phase 3 | United States;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 20 | EUCTR2018-004009-22-DE (EUCTR) | 21/08/2019 | Study of WVE-210201 in Patients (able to walk independently) with Duchenne Muscular Dystrophy | A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 with Open-label Extension in Ambulatory Patients with Duchenne Muscular Dystrophy (DYSTANCE 51) | Duchenne muscular dystrophy MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: Duchenne muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: WVE-210201 Product Code: WVE-210201 INN or Proposed INN: WVE-210201 Other descriptive name: suvodirsen | Wave Life Sciences UK Limited | NULL | Not Recruiting | Female: no Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Germany;Japan;Sweden;Netherlands;Australia;Belgium;Poland;Canada;Czech Republic;France;Italy;United Kingdom;Turkey;Ireland;Spain;United States |