Givinostat ( DrugBank: Givinostat )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
107若年性特発性関節炎8
113筋ジストロフィー22

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01557452
(ClinicalTrials.gov)
December 201114/3/2012An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Poly Juvenile Idiopathic Arthritis (JIA)An Open-Label Extension of the Dose Finding Study (DSC/08/2357/36) in Patients With Polyarticular Course Juvenile Idiopathic Arthritis (Poly JIA) JIAJuvenile Idiopathic ArthritisDrug: GivinostatItalfarmacoParexelTerminated2 Years18 YearsBoth1N/ACzech Republic
2EUCTR2011-003341-18-CZ
(EUCTR)
14/10/201105/09/2011NAPAn Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) - - Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;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 (hydrochloride-monohydrate)
Other descriptive name: Diethyl-[6-(4-hydroxycarbamoyl- phenyl carbamoyloxymethyl)-naphthalen-2-yl methyl]-ammonium chloride; monohydrate
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
3Czech Republic
3EUCTR2010-019094-15-BE
(EUCTR)
07/12/201020/05/2010A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentA multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Czech Republic;Slovenia;Spain;Belgium;Italy
4NCT01261624
(ClinicalTrials.gov)
October 201015/12/2010Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic ArthritisA Multicenter, Open Label, Dose Finding Study to Evaluate Efficacy and Safety of Givinostat Administered in Two Different Doses in Patients With Poly JIA Not Adequately Responding to the Standard Treatment.Polyarticular Course Juvenile Idiopathic ArthritisDrug: GivinostatItalfarmacoNULLTerminated2 Years17 YearsAll16Phase 2Belgium;Czech Republic;Italy;Romania;Serbia;Slovenia;Spain
5EUCTR2010-019094-15-ES
(EUCTR)
06/09/201026/05/2010Estudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentEstudio multicéntrico y abierto, de búsqueda de dosis para evaluar eficacia y seguridad de Givinostat administrado en dos dosis diferentes en pacientes que cursan artritis idiopática juvenil de evolución poliarticular (AIJ poli) que no están respondiendo adecuadamente al tratamiento estándar / A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Artritis Idiopática Juvenil de evolución poliarticular (AIJ poli) / Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
6EUCTR2010-019094-15-SI
(EUCTR)
17/08/201022/06/2010A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentA multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
7EUCTR2010-019094-15-IT
(EUCTR)
12/07/201027/05/2010A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36A multicenter, open label dose finding study to evaluate preliminary efficacy and safety profile of Givinostat in subjects with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment - DSC/08/2357/36 polyarticular course Juvenile Idiopathic Arthritis in ethe following forms: - RF positive and negative polyarthritis - systemic arthritis without systemic features - extended oligoarthritis
MedDRA version: 12.1;Level: LLT;Classification code 10036036;Term: Polyarticular JCA
Product Code: Givinostat
INN or Proposed INN: Givinostat
ITALFARMACONULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy
8EUCTR2010-019094-15-CZ
(EUCTR)
01/07/201017/05/2010A multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatmentA multicenter, open label, dose finding study to evaluate efficacy and safety of Givinostat administered in two different doses in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA) not adequately responding to the standard treatment Polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
MedDRA version: 12.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis
Product Name: Givinostat
Product Code: ITF2357
INN or Proposed INN: Givinostat (hydrochloride-monohydrate)
Italfarmaco S.p.A.NULLNot RecruitingFemale: yes
Male: yes
20Czech Republic;Slovenia;Spain;Italy

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04821063
(ClinicalTrials.gov)
April 13, 202126/3/2021Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC IntervalA Randomized, Partially Double-Blind, Four-Period, Four-Treatment, Crossover Study Investigating the Placebo-Corrected Effects of a Therapeutic Dose (100 mg) and a Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval in Healthy Male and Female SubjectsDuchenne and Becker Muscular Dystrophy;Polycytemia VeraDrug: ITF2357 10 mg/mL;Drug: Placebo;Drug: Moxifloxacin HydrochlorideItalfarmacoNULLCompleted18 Years55 YearsAll31Phase 1Canada
2EUCTR2017-000397-10-GB
(EUCTR)
20/01/202015/03/2019Study 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 thepastOpen 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
185Phase 3Canada;Netherlands;Belgium;United States;United Kingdom;Italy;Germany;Spain;France
3EUCTR2017-000397-10-NL
(EUCTR)
01/10/201906/11/2019Study 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 pastOpen 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
222Phase 3France;United States;Serbia;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
4EUCTR2017-000397-10-BE
(EUCTR)
12/06/201912/02/2019Study 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 pastOpen 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
185Phase 3United States;France;Canada;Spain;Belgium;Netherlands;Germany;United Kingdom;Italy
5EUCTR2017-000397-10-ES
(EUCTR)
16/05/201911/04/2019Study 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 pastOpen 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 study long term 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.NULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
185 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
6EUCTR2017-001629-41-NL
(EUCTR)
15/11/201831/05/2018Study to evaluate the micro-macroscopic effects on muscles, the safety and tolerability, and the efficacy of givinostat in patients with Becker Muscular DystrophyA 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.NULLNot RecruitingFemale: no
Male: yes
48Phase 2Netherlands;Italy
7NCT03238235
(ClinicalTrials.gov)
December 12, 201712/7/2017Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular DystrophyA Randomised, Double Blind, Placebo Controlled Study to Evaluate the Micro-macroscopic Effects on Muscles, the Safety and Tolerability, and the Efficacy of Givinostat in Patients With Becker Muscular Dystrophy (BMD)Becker Muscular DystrophyDrug: givinostat;Drug: placeboItalfarmacoNULLActive, not recruiting18 Years65 YearsMale51Phase 2Italy;Netherlands
8NCT03373968
(ClinicalTrials.gov)
October 24, 20174/12/2017Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability StudyOpen Label, Long-term Safety, Tolerability, and Efficacy Study of GIVINOSTAT in All DMD Patients Who Have Been Previously Treated in One of the GIVINOSTAT StudiesDuchenne Muscular DystrophyDrug: GivinostatItalfarmacoCromsourceEnrolling by invitation7 YearsN/AMale206Phase 2/Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Serbia;Spain;United Kingdom
9EUCTR2017-001629-41-IT
(EUCTR)
08/09/201715/01/2021Study 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 of givinostat in patients with Becker Muscular Dystrophy - NA Becker Muscular Dystrophy (BMD)
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.NULLNot RecruitingFemale: no
Male: yes
55Phase 2Netherlands;Italy
10EUCTR2017-000397-10-IT
(EUCTR)
31/07/201730/01/2018Studio nel quale tutti i pazienti prendono lo stesso farmaco sperimentale con lo scopo di valutare a lungo termine la sicurezza, la tollerabilità e l'efficacia del GIVINOSTAT in pazienti affetti da distrofia muscolare di Duchenne che sono stati precedentemente trattati in uno studio con GIVINOSTAT.Studio in aperto a lungo termine volto a valutare la sicurezza, la tollerabilità e l'efficacia di GIVINOSTAT in pazienti affetti da distrofia muscolare di Duchenne che sono stati precedentemente trattati in studio con GIVINOSTAT. - Studio con Givinostat in DMD a lungo termine Distrofia Muscolare di Duchenne (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 (idrocloruro monoidrato)
Product Code: ITF2357
INN or Proposed INN: Givinostat (idrocloruro monoidrato)
Other descriptive name: GIVINOSTAT
ITALFARMACO S.p.A.NULLAuthorised-recruitment may be ongoing or finished Female: no
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
11EUCTR2016-000401-36-NL
(EUCTR)
28/06/201714/12/2016Study 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.NULLNot RecruitingFemale: no
Male: yes
169Phase 3France;United States;Serbia;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy
12NCT02851797
(ClinicalTrials.gov)
June 1, 201727/7/2016Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular DystrophyRandomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular DystrophyDuchenne Muscular DystrophyDrug: givinostat;Drug: placeboItalfarmacoSyneos HealthCompleted6 Years17 YearsMale179Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Serbia;Spain;United Kingdom
13EUCTR2016-000401-36-IT
(EUCTR)
24/05/201708/02/2017Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
192Phase 3France;United States;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
14EUCTR2016-000401-36-DE
(EUCTR)
15/05/201728/10/2016Study 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.NULLNot RecruitingFemale: no
Male: yes
169Phase 3United States;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
15EUCTR2016-000401-36-GB
(EUCTR)
07/03/201726/10/2016Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
169Phase 3United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom
16EUCTR2016-000401-36-ES
(EUCTR)
10/02/201710/02/2017Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
192Phase 3France;United States;Canada;Belgium;Spain;Israel;Netherlands;Germany;Italy;United Kingdom
17EUCTR2016-000401-36-BE
(EUCTR)
27/01/201727/10/2016Study 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.NULLNot RecruitingFemale: no
Male: yes
242Phase 3United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
18NCT01761292
(ClinicalTrials.gov)
April 201320/12/2012A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMDA 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 DystrophyDuchenne Muscular Dystrophy (DMD)Drug: GivinostatItalfarmacoNULLCompleted7 Years11 YearsMale20Phase 1/Phase 2Italy
19EUCTR2012-002566-12-IT
(EUCTR)
04/02/201317/10/2012A 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 DystrophyA 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
ITALFARMACONULLNot RecruitingFemale: no
Male: yes
20Phase 2Italy
20EUCTR2016-000401-36-FR
(EUCTR)
16/05/2017Study 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.NULLNot RecruitingFemale: no
Male: yes
192Phase 3United States;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
21EUCTR2017-000397-10-DE
(EUCTR)
22/01/2019Study 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 pastOpen 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
222Phase 3France;United States;Serbia;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
22EUCTR2017-000397-10-FR
(EUCTR)
09/09/2019Study 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 pastOpen 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.NULLNAFemale: no
Male: yes
185Phase 3United States;France;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom