Givinostat (hydrochloride monohydrate)    (DrugBank: Givinostat)

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10

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.
10 / 567 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000397-10-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 3France;United States;Canada;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
2EUCTR2017-000397-10-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
185Phase 3United States;France;Canada;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy
3EUCTR2017-000397-10-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
4EUCTR2017-001629-41-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
48Phase 2Netherlands
5EUCTR2016-000401-36-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-000401-36-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
7EUCTR2016-000401-36-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
8EUCTR2017-000397-10-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
185Phase 3United States;Serbia;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy
9EUCTR2017-000397-10-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
10EUCTR2016-000401-36-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.NULLNAFemale: no
Male: yes
192Phase 3United States;France;Canada;Spain;Belgium;Israel;Netherlands;Germany;Italy;United Kingdom