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.
| 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 | EUCTR2017-000397-10-GB (EUCTR) | 20/01/2020 | 15/03/2019 | Study in which all the patients take the same investigational drug with theaim of evaluate the long-term safety, tolerability, and efficacy ofGIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophywho have been already treated in one of the GIVINOSTAT studies in thepast | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies. - Givinostat DMD long term study | 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: GIVINOSTAT (hyrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 185 | Phase 3 | France;United States;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2017-000397-10-NL (EUCTR) | 01/10/2019 | 06/11/2019 | Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | 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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 185 | Phase 3 | United States;France;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy | ||
| 3 | EUCTR2017-000397-10-BE (EUCTR) | 12/06/2019 | 12/02/2019 | Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | 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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 185 | Phase 3 | United States;France;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2017-001629-41-NL (EUCTR) | 15/11/2018 | 31/05/2018 | Study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy of givinostat in patients with Becker Muscular Dystrophy | A randomised, double-blind, placebo-controlled study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy ofgivinostat in patients with Becker Muscular Dystrophy - NA | Distrofia Muscolare di Becker (DMB) MedDRA version: 20.0;Level: PT;Classification code 10059117;Term: Becker's muscular dystrophy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 48 | Phase 2 | Netherlands | ||
| 5 | EUCTR2016-000401-36-IT (EUCTR) | 24/05/2017 | 08/02/2017 | Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.1;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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 192 | Phase 3 | France;United States;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 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 | EUCTR2016-000401-36-GB (EUCTR) | 07/03/2017 | 26/10/2016 | Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. - EPIDYS | 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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 169 | Phase 3 | United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 7 | EUCTR2016-000401-36-ES (EUCTR) | 10/02/2017 | 10/02/2017 | Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.1;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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 192 | Phase 3 | France;United States;Canada;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2012-002566-12-IT (EUCTR) | 04/02/2013 | 17/10/2012 | A Two-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, and Effects on Histology and Different Clinical Parameters of Givinostat in Ambulant Children with Duchenne Muscular Dystrophy | A Two-Part Study to Assess the Safety and Tolerability, Pharmacokinetics, and Effects on Histology and Different Clinical Parameters of Givinostat in Ambulant Children with Duchenne Muscular Dystrophy - DSC | Duchenne Muscular Dystrophy MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat Other descriptive name: givinostat Product Name: Givinostat Product Code: ITF2357 INN or Proposed INN: Givinostat Other descriptive name: Givinostat | ITALFARMACO | NULL | Not Recruiting | Female: no Male: yes | 20 | Phase 2 | Italy | ||
| 9 | EUCTR2016-000401-36-FR (EUCTR) | 16/05/2017 | Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular Dystrophy. | 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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | NA | Female: no Male: yes | 192 | Phase 3 | United States;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 10 | EUCTR2017-000397-10-FR (EUCTR) | 09/09/2019 | Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | 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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | NA | Female: no Male: yes | 185 | Phase 3 | United States;France;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom | |||
| 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 | EUCTR2017-000397-10-DE (EUCTR) | 22/01/2019 | Study in which all the patients take the same investigational drug with the aim of evaluate the long-term safety, tolerability, and efficacy of GIVINOSTAT in all the patients affected with Duchenne Muscolar Dystrophy who have been already treated in one of the GIVINOSTAT studies in the past | Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies - Givinostat DMD long term study | 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: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinostat (hydrochloride monohydrate) Other descriptive name: GIVINOSTAT | ITALFARMACO S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | 185 | Phase 3 | United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy |