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Ns-065/ncnp-01    (DrugBank: -)

1 disease
告示番号疾患名（ページ内リンク）臨床試験数
113筋ジストロフィー7

113. 筋ジストロフィー　［臨床試験数：567，薬物数：442（DrugBank：93），標的遺伝子数：55，標的パスウェイ数：151］
Searched query = "Muscular dystrophy", "Dystrophinopathies", "Myotilinopathy", "Laminopathy", "Caveolinopathy", "LGMD1C", "Desminopathy", "Sarcoglycanopathy", "α-dystroglycanopathy", "FCMD", "Walker-Warburg syndrome", "Muscle-eye-brain disease", "Myotonic dystrophy", "Integrin α7 deficient CMD", "Rigid spine syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 567 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2019-002076-13-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;Taiwan;Greece;Spain;Turkey;Chile;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Japan;Sweden;Korea, Republic of
2EUCTR2019-002076-13-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;Taiwan;Greece;Spain;Turkey;Chile;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Japan;Sweden;Korea, Republic of
3EUCTR2019-002076-13-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 3United States;Taiwan;Spain;Turkey;Chile;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Brazil;Poland;Australia;Netherlands;Japan;Sweden;Korea, Republic of
4NCT03167255
(ClinicalTrials.gov)		July 6, 201722/5/2017Extension Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)A Phase II, Open-Label, Extension Study to Assess the Safety and Efficacy of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: NS-065/NCNP-01NS Pharma, Inc.Nippon Shinyaku Co., Ltd.;Cooperative International Neuromuscular Research Group;Therapeutic Research in Neuromuscular Disorders Solutions (TRiNDS)Active, not recruiting4 Years10 YearsMale16Phase 2United States;Canada
5NCT02740972
(ClinicalTrials.gov)		December 201623/3/2016Safety and Dose Finding Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)Duchenne Muscular DystrophyDrug: NS-065/NCNP-01;Drug: PlaceboNS Pharma, Inc.Nippon Shinyaku Co., Ltd.;Cooperative International Neuromuscular Research Group;Therapeutic Research in Neuromuscular Disorders SolutionsCompleted4 Years9 YearsMale16Phase 2United States;Canada
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6NCT02081625
(ClinicalTrials.gov)		June 20135/3/2014Exploratory Study of NS-065/NCNP-01 in DMDExploratory Study of NS-065/NCNP-01 in Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: NS-065/NCNP-01National Center of Neurology and Psychiatry, JapanNippon Shinyaku Co., Ltd.Completed5 Years18 YearsMale10Phase 1Japan
7EUCTR2019-002076-13-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

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