113. Muscular dystrophy Clinical trials / Disease details


Clinical trials : 622 Drugs : 485 - (DrugBank : 99) / Drug target genes : 59 - Drug target pathways : 168

  
18 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2021-000122-10-GR
(EUCTR)
25/11/202113/10/2021A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD)A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of
2EUCTR2019-002076-13-NO
(EUCTR)
08/09/202118/02/2021This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Netherlands;Norway;China;Japan;New Zealand;Sweden;Korea, Republic of
3EUCTR2020-003653-30-ES
(EUCTR)
26/07/202115/12/2021A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls - Galactic-53 A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls - Galactic-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
20Phase 2United States;Spain;Turkey;Russian Federation;Italy;China
4NCT04956289
(ClinicalTrials.gov)
July 1, 202130/6/2021Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMDA Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With Duchenne Muscular Dystrophy (DMD) Compared to Natural History ControlsDuchenne Muscular DystrophyDrug: ViltolarsenNS Pharma, Inc.Nippon Shinyaku Co., Ltd.Recruiting8 YearsN/AMale20Phase 2United States;Italy;Russian Federation;Spain;Turkey
5EUCTR2021-000122-10-NL
(EUCTR)
30/06/202108/04/2021A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD)A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of
6EUCTR2021-000122-10-ES
(EUCTR)
15/06/202130/07/2021A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD)A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of
7NCT04687020
(ClinicalTrials.gov)
June 10, 202116/12/2020Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)Long-term Use of Viltolarsen in Boys With Duchenne Muscular Dystrophy in Clinical Practice (VILT-502)Duchenne Muscular DystrophyDrug: ViltolarsenNS Pharma, Inc.NULLEnrolling by invitationN/AN/AMale16Phase 4United States;Canada
8EUCTR2020-003653-30-IT
(EUCTR)
08/06/202108/06/2021This is an Open-label Study to evaluate the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys with Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls - Galactic-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: [NS-065/NCNP-01]
INN or Proposed INN: VILTOLARSEN
NS Pharma, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
20Phase 2United States;Spain;Turkey;Russian Federation;China;Italy
9EUCTR2021-000122-10-IT
(EUCTR)
26/04/202108/06/2021A Phase 3 study of Viltolarsen in boys with Duchenne Muscular Dystrophy (DMD)A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53X Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: [NS-065/NCNP-01]
INN or Proposed INN: VILTOLARSEN
NS Pharma, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Korea, Republic of
10NCT04768062
(ClinicalTrials.gov)
April 13, 202119/2/2021Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With DMD (RACER53-X)A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: ViltolarsenNS Pharma, Inc.Nippon Shinyaku Co., Ltd.Enrolling by invitationN/AN/AMale74Phase 3Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Russian Federation;Spain;Turkey
11EUCTR2019-002076-13-GR
(EUCTR)
12/11/202024/09/2020This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Sweden;Korea, Republic of
12NCT04060199
(ClinicalTrials.gov)
April 14, 202015/8/2019Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: Viltolarsen;Drug: PlaceboNS Pharma, Inc.Nippon Shinyaku Co., Ltd.Recruiting4 Years7 YearsMale74Phase 3United States;Australia;Canada;Chile;Greece;Hong Kong;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Norway;Russian Federation;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Sweden
13EUCTR2019-002076-13-NL
(EUCTR)
03/03/202025/11/2019This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Turkey;Chile;Russian Federation;United Kingdom;Italy;Mexico;Canada;Australia;Norway;Netherlands;China;Japan;New Zealand;Sweden;Korea, Republic of
14EUCTR2019-002076-13-GB
(EUCTR)
02/03/202016/09/2019This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3Korea, Republic of;Sweden;Japan;Netherlands;Australia;Poland;Brazil;Belgium;Canada;France;Italy;United Kingdom;Russian Federation;Chile;Turkey;Spain;Taiwan;United States
15EUCTR2019-002076-13-IT
(EUCTR)
27/01/202005/01/2021This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: [NS-065/NCNP-01]
INN or Proposed INN: VILTOLARSEN
NS Pharma, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
74Phase 3United States;Taiwan;Greece;Spain;Turkey;Chile;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Brazil;Belgium;Australia;Netherlands;Japan;Sweden;Korea, Republic of
16EUCTR2019-002076-13-ES
(EUCTR)
16/12/201906/11/2019This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
74 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Spain;Turkey;Russian Federation;Chile;United Kingdom;Italy;France;Canada;Poland;Belgium;Brazil;Australia;Netherlands;Japan;Sweden;Korea, Republic of
17NCT04337112
(ClinicalTrials.gov)
January 23, 20082/4/2020The Expanded Access Use of Viltolarsen in Duchenne Muscular Dystrophy With Confirmed Exon 53 Amenable MutationThe Expanded Access Use of Viltolarsen for the Treatment of Duchenne Muscular Dystrophy (DMD) Amenable to Exon 53 SkippingMuscular Dystrophy, Duchenne;DMDDrug: viltolarsenNS Pharma, Inc.NULLApproved for marketing3 Years12 YearsMaleNULL
18EUCTR2019-002076-13-SE
(EUCTR)
17/10/2019This is a randomized, double-blind, Placebo-controlled sudy to evaluate the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD) - RACER-53 Duchenne Muscular Dystrophy (DMD)
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] - Musculoskeletal Diseases [C05]
Product Name: Viltolarsen
Product Code: NS-065/NCNP-01
INN or Proposed INN: VILTOLARSEN
NS Pharma, Inc.NULLNot RecruitingFemale: no
Male: yes
74Phase 3United States;Taiwan;Spain;Turkey;Chile;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Japan;Sweden;Korea, Republic of