PS188 ( 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 | 6 |
113. 筋ジストロフィー
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 | EUCTR2015-003681-87-BE (EUCTR) | 12/01/2016 | 16/11/2015 | A study to assess the effect of BMN 044 in subjects with Duchenne muscular dystrophy (Extension study) | A multi center, multi national, open label, extension study to evaluate the long-term efficacy and safety of BMN 044 (PRO044) in subjects with Duchenne muscular dystrophy | Duchenne muscular dystrophy MedDRA version: 18.1;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: BMN 044 Product Code: BMN 044 INN or Proposed INN: PS188 (company code) Other descriptive name: PS188 Product Name: BMN 044 Product Code: BMN 044 INN or Proposed INN: PS188 (company code) Other descriptive name: PS188 | BioMarin Pharmaceutical Inc. | NULL | Not Recruiting | Female: no Male: yes | 50 | Phase 2 | United States;Belgium;Netherlands;Italy;Sweden | ||
| 2 | EUCTR2013-003605-26-NL (EUCTR) | 13/04/2015 | 19/11/2014 | A study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy (Extension study to PRO044-CLIN-01) | A phase II, open label, extension study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy | Duchenne muscular dystrophy MedDRA version: 17.1;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: PRO044 Product Code: PRO044 INN or Proposed INN: PS188 (company code) Other descriptive name: PS188 | Prosensa Therapeutics B.V. | NULL | Not Recruiting | Female: no Male: yes | 18 | Phase 2 | Belgium;Netherlands;Sweden | ||
| 3 | EUCTR2013-003605-26-BE (EUCTR) | 23/01/2015 | 04/12/2014 | A study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy (Extension study to PRO044-CLIN-01) | A phase II, open label, extension study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy | Duchenne muscular dystrophy MedDRA version: 18.0;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: PRO044 Product Code: PRO044 INN or Proposed INN: PS188 (company code) Other descriptive name: PS188 | Prosensa Therapeutics B.V. | NULL | Not Recruiting | Female: no Male: yes | 18 | Phase 2 | Belgium;Netherlands;Sweden | ||
| 4 | EUCTR2013-003605-26-IT (EUCTR) | 02/12/2014 | 11/09/2014 | A study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy (Extension study to PRO044-CLIN-01) | A phase II, open label, extension study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy | Duchenne muscular dystrophy MedDRA version: 17.0;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: PRO044 Product Code: PRO044 INN or Proposed INN: PS188 (company code) Other descriptive name: PS188 | Prosensa Therapeutics B.V. | NULL | Not Recruiting | Female: no Male: yes | 18 | Phase 2 | Belgium;Netherlands;Italy;Sweden | ||
| 5 | EUCTR2013-003605-26-SE (EUCTR) | 26/11/2014 | 26/09/2014 | A study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy (Extension study to PRO044-CLIN-01) | A phase II, open label, extension study to assess the effect of PRO044 in patients with Duchenne muscular dystrophy | Duchenne muscular dystrophy MedDRA version: 18.1;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: PRO044 Product Code: PRO044 INN or Proposed INN: PS188 (company code) Other descriptive name: PS188 | BioMarin Nederland B.V. | NULL | Not Recruiting | Female: no Male: yes | 18 | Phase 2 | Belgium;Netherlands;Sweden | ||
| 6 | EUCTR2015-003681-87-IT (EUCTR) | 19/01/2021 | A study to assess the effect of BMN 044 in subjects with Duchennemuscular dystrophy (Extension study) | A multi center, multi national, open label, extension study to evaluate the long-term efficacy and safety of BMN 044 (PRO044) in subjects with Duchenne muscular dystrophy - NA | 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] - Musculoskeletal Diseases [C05] | Product Name: BMN 044 Product Code: BMN 044 Other descriptive name: PS188 Product Name: BMN 044 Product Code: BMN 044 INN or Proposed INN: PS188 Other descriptive name: PS188 | BIOMARIN PHARMACEUTICAL INC. | NULL | NA | Female: no Male: yes | 50 | Phase 2 | Netherlands;Italy;Sweden;United States;Belgium |