113. 筋ジストロフィー Muscular dystrophy Clinical trials / Disease details


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170

  
4 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-004139-35-IT
(EUCTR)
31/08/201817/06/2021Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy - Clinical Trial in Male Subjects with Muscular Disease Duchenne Muscular Distrophy
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: Cosintropina acetato
Product Code: [MNK-1411]
INN or Proposed INN: TETRACOSACTIDE ESACETATO
Other descriptive name: Cosyntropin acetate
Trade Name: Synacthen Ampoules 250 mcg
Product Name: Synacthen Ampoules 250 microgrammi
Product Code: [Synacthen Ampoules 250 microgrammi]
INN or Proposed INN: TETRACOSACTIDE
MALLINCKRODT ARD INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
132Phase 2Serbia;United States;Spain;Costa Rica;Ukraine;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Puerto Rico;Poland;Bulgaria
2EUCTR2017-004139-35-BG
(EUCTR)
28/08/201828/06/2018Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy Duchenne Muscular Distrophy
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: Cosyntropin acetate
Product Code: MNK-1411
INN or Proposed INN: TETRACOSACTIDE HEXAACETATE
Other descriptive name: Cosyntropin acetate
Mallinckrodt ARD Inc.NULLNot Recruiting Female: no
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Bulgaria;Germany;Netherlands
3EUCTR2017-004139-35-BE
(EUCTR)
18/06/201803/04/2018Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy Duchenne Muscular Distrophy
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: Cosyntropin acetate
Product Code: MNK-1411
INN or Proposed INN: TETRACOSACTIDE HEXAACETATE
Other descriptive name: Cosyntropin acetate
Mallinckrodt ARD Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
132Phase 2United States;Serbia;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Germany;Netherlands
4EUCTR2017-004139-35-ES
(EUCTR)
12/06/201819/03/2018Clinical Trial in Male Subjects with Muscular DiseaseA Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy Duchenne Muscular Distrophy
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: Cosyntropin acetate
Product Code: MNK-1411
INN or Proposed INN: TETRACOSACTIDE HEXAACETATE
Other descriptive name: Cosyntropin acetate
Mallinckrodt ARD Inc.NULLNot Recruiting Female: no
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Bulgaria;Germany;Netherlands