Golodirsen (DrugBank: Golodirsen)
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 | 11 |
| 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 | EUCTR2017-004625-32-BG (EUCTR) | 03/12/2020 | 28/10/2020 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53Skipping 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: SRP-4045 Product Code: SRP-4045 INN or Proposed INN: CASIMERSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 45 skipping Product Name: SRP-4053 Product Code: SRP-4053 INN or Proposed INN: GOLODIRSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 53 skipping | Sarepta Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 150 | Phase 3 | United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Sweden | ||
| 2 | EUCTR2017-004625-32-SE (EUCTR) | 17/06/2020 | 09/08/2018 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53Skipping 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: SRP-4045 Product Code: SRP-4045 INN or Proposed INN: CASIMERSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 45 skipping Product Name: SRP-4053 Product Code: SRP-4053 INN or Proposed INN: GOLODIRSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 53 skipping | Sarepta Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 260 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Sweden | ||
| 3 | NCT04179409 (ClinicalTrials.gov) | February 18, 2020 | 12/8/2019 | A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of Casimersen, Eteplirsen and Golodirsen in Subjects With Duchenne Muscular Dystrophy Carrying Eligible DMD Duplications | A 48-Week, Open Label, Study to Evaluate the Efficacy and Safety of Casimersen, Eteplirsen and Golodirsen in Subjects With Duchenne Muscular Dystrophy Carrying Eligible DMD Duplications | Duchenne Muscular Dystrophy | Drug: Casimersen;Drug: Eteplirsen;Drug: Golodirsen | Kevin Flanigan | Sarepta Therapeutics, Inc. | Enrolling by invitation | 6 Months | N/A | Male | 6 | Phase 2 | United States |
| 4 | EUCTR2017-004625-32-FR (EUCTR) | 05/02/2019 | 23/07/2018 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53 Skipping 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] | Sarepta Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 260 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Sweden | |||
| 5 | EUCTR2017-004625-32-BE (EUCTR) | 20/12/2018 | 10/09/2018 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53 Skipping 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] | Sarepta Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 150 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Sweden | |||
| 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 |
| 6 | EUCTR2017-004625-32-ES (EUCTR) | 07/09/2018 | 10/09/2018 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53Skipping 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: SRP-4045 Product Code: SRP-4045 INN or Proposed INN: CASIMERSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 45 skipping Product Name: SRP-4053 Product Code: SRP-4053 INN or Proposed INN: GOLODIRSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 53 skipping | Sarepta Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 150 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Sweden | ||
| 7 | NCT03532542 (ClinicalTrials.gov) | August 2, 2018 | 10/5/2018 | An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy | Long-term, Open-label Extension Study for Patients With Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen | Duchenne Muscular Dystrophy | Drug: Casimersen;Drug: Golodirsen | Sarepta Therapeutics, Inc. | NULL | Enrolling by invitation | 7 Years | 23 Years | Male | 260 | Phase 3 | United States;Belgium;Czechia;Germany;Israel;Italy;Spain;Sweden;United Kingdom |
| 8 | EUCTR2017-004625-32-GB (EUCTR) | 26/07/2018 | 23/01/2019 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53Skipping 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: SRP-4045 Product Code: SRP-4045 INN or Proposed INN: CASIMERSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 45 skipping Product Name: SRP-4053 Product Code: SRP-4053 INN or Proposed INN: GOLODIRSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 53 skipping | Sarepta Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 260 | Phase 3 | United States;Finland;Spain;Ireland;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Sweden | ||
| 9 | EUCTR2017-004625-32-CZ (EUCTR) | 09/09/2019 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53 Skipping 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] | Sarepta Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 260 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Sweden | ||||
| 10 | EUCTR2017-004625-32-PL (EUCTR) | 07/11/2019 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53Skipping 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: SRP-4045 Product Code: SRP-4045 INN or Proposed INN: CASIMERSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 45 skipping Product Name: SRP-4053 Product Code: SRP-4053 INN or Proposed INN: GOLODIRSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 53 skipping | Sarepta Therapeutics, Inc. | NULL | NA | Female: no Male: yes | 260 | Phase 3 | United States;Finland;Spain;Ireland;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Australia;Germany;Sweden | |||
| 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 |
| 11 | EUCTR2017-004625-32-DE (EUCTR) | 26/07/2018 | A long-term extension study of a new investigational medicinal product for the treatment of Duchenne Muscular Dystrophy patients | Long-term, Open-label Extension Study for Patients with Duchenne Muscular Dystrophy Enrolled in Clinical Trials Evaluating Casimersen or Golodirsen - N/A | Patients with Duchenne Muscular Dystrophy Amenable to Exon 45 or 53Skipping 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: SRP-4045 Product Code: SRP-4045 INN or Proposed INN: CASIMERSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 45 skipping Product Name: SRP-4053 Product Code: SRP-4053 INN or Proposed INN: GOLODIRSEN Other descriptive name: Phosphorodiamidate morpholino oligomer for exon 53 skipping | Sarepta Therapeutics, Inc. | NULL | NA | Female: no Male: yes | 260 | Phase 3 | United States;Czechia;Finland;Spain;Ireland;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Bulgaria;Germany;Sweden |