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

18 trials found

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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	NCT04821063 (ClinicalTrials.gov)	April 13, 2021	26/3/2021	Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 ...	A Randomized, Partially Double-Blind, Four-Period, Four-Treatment, Crossover Study Investigating the ...	Duchenne and Becker Muscular Dystrophy;Polycytemia Vera	Drug: ITF2357 10 mg/mL;Drug: Placebo;Drug: Moxifloxacin Hydrochloride	Italfarmaco	NULL	Completed	18 Years	55 Years	All	31	Phase 1	Canada
2	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- ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: GIVINOSTAT (hyrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinost ...	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
3	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 ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	222	Phase 3	France;United States;Serbia;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
4	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 ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	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
5	EUCTR2017-000397-10-ES (EUCTR)	16/05/2019	11/04/2019	Study in which all the patients take the same investigational drug with the aim of evaluate the long ...	Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	185	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France;United States;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
6	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 eff ...	A randomised, double-blind, placebo-controlled study to evaluate the micro-macroscopic effects on mu ...	Distrofia Muscolare di Becker (DMB) MedDRA version: 20.0;Level: PT;Classification code 10059117;Term ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	ITALFARMACO S.P.A.	NULL	Not Recruiting			Female: no Male: yes	48	Phase 2	Netherlands;Italy
7	EUCTR2017-001629-41-IT (EUCTR)	08/09/2017	15/01/2021	Study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the eff ...	A randomised, double-blind, placebo-controlled study to evaluate the micro-macroscopic effects on mu ...	Becker Muscular Dystrophy (BMD) MedDRA version: 20.0;Level: PT;Classification code 10059117;Term: Be ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	ITALFARMACO S.P.A.	NULL	Not Recruiting			Female: no Male: yes	55	Phase 2	Netherlands;Italy
8	EUCTR2017-000397-10-IT (EUCTR)	31/07/2017	30/01/2018	Studio nel quale tutti i pazienti prendono lo stesso farmaco sperimentale con lo scopo di valutare a ...	Studio in aperto a lungo termine volto a valutare la sicurezza, la tollerabilità e l'efficacia di GI ...	Distrofia Muscolare di Duchenne (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Te ...	Product Name: Givinostat (idrocloruro monoidrato) Product Code: ITF2357 INN or Proposed INN: Givinostat ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	100	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	France;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
9	EUCTR2016-000401-36-NL (EUCTR)	28/06/2017	14/12/2016	Study to evaluate the efficacy and safety of givinostat in ambulant patients with Duchenne Muscular ...	Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 20.0;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	ITALFARMACO S.p.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	169	Phase 3	France;United States;Serbia;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
10	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 ...	Randomised, double blind, placebo controlled, multicentre study to evaluate the efficacy and safety ...	Duchenne Muscular Dystrophy (DMD) MedDRA version: 19.1;Level: PT;Classification code 10013801;Term: ...	Product Name: Givinostat (hydrochloride monohydrate) Product Code: ITF2357 INN or Proposed INN: Givinos ...	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

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