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 | EUCTR2017-004139-35-IT (EUCTR) | 31/08/2018 | 17/06/2021 | Clinical Trial in Male Subjects with Muscular Disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 132 | Phase 2 | Serbia;United States;Spain;Costa Rica;Ukraine;Ireland;Turkey;Israel;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Puerto Rico;Poland;Bulgaria | ||
| 2 | EUCTR2017-004139-35-BG (EUCTR) | 28/08/2018 | 28/06/2018 | Clinical Trial in Male Subjects with Muscular Disease | A 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. | NULL | Not 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): no | Serbia;United States;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Bulgaria;Germany;Netherlands | ||
| 3 | NCT03400852 (ClinicalTrials.gov) | July 17, 2018 | 9/1/2018 | A Study to Assess the Efficacy and Safety of MNK-1411 in Duchenne Muscular Dystrophy | A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Participants 4 to 8 Years of Age With Duchenne Muscular Dystrophy | Muscular Dystrophy, Duchenne | Drug: Cosyntropin;Other: Placebo | Mallinckrodt ARD LLC | NULL | Terminated | 4 Years | 8 Years | Male | 44 | Phase 2 | United States;Bulgaria;Israel;Italy;Mexico;Serbia;Spain;Turkey |
| 4 | EUCTR2017-004139-35-BE (EUCTR) | 18/06/2018 | 03/04/2018 | Clinical Trial in Male Subjects with Muscular Disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 132 | Phase 2 | United States;Serbia;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Germany;Netherlands | ||
| 5 | EUCTR2017-004139-35-ES (EUCTR) | 12/06/2018 | 19/03/2018 | Clinical Trial in Male Subjects with Muscular Disease | A 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. | NULL | Not 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): no | United States;Serbia;Spain;Turkey;Chile;Israel;United Kingdom;Italy;Canada;Argentina;Belgium;Bulgaria;Germany;Netherlands |