RILUZOLO ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
18脊髄小脳変性症(多系統萎縮症を除く。)1
114非ジストロフィー性ミオトニー症候群1

2. 筋萎縮性側索硬化症


臨床試験数 : 624 薬物数 : 623 - (DrugBank : 160) / 標的遺伝子数 : 172 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-005367-32-IT
(EUCTR)
29/02/201617/03/2017Clinical study on the efficacy and tolerabilty of Guabenz in Amiotropic Lateral SclerosisPROTEIN MISFOLDING, AMYOTROPHIC LATERAL SCLEROSIS AND GUANABENZ: A PHASE II RCT WITH FUTILITY DESIGN - PROMISE Amiotrophic Lateral Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028003;Term: Motor neurone disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GUANABENZ ACETATO
Product Code: GUANA2015
INN or Proposed INN: GUANABENZ
Other descriptive name: GUANABENZ
Product Name: RILUZOLO
INN or Proposed INN: RILUZOLO
Other descriptive name: RILUZOLO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Phase 2Italy

18. 脊髄小脳変性症(多系統萎縮症を除く。)


臨床試験数 : 71 薬物数 : 101 - (DrugBank : 30) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 65
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000282-37-IT
(EUCTR)
26/02/202017/06/2021Riluzole in spinocerebellar ataxia type 7Riluzole (Glentek) in patients with SpinoCerebellar Ataxia type 7: a randomized, double-blind, placebo-controlled pilot trial with a lead in phase - RISCA7 Spinocerebellar ataxia type 7 (SCA7)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Glentek 50 mg film-coated tablets
Product Name: Glentek 50 mg compresse rivestite con film
Product Code: [Glentek 50 mg compresse rivestite con film]
INN or Proposed INN: Riluzolo
DIPARTIMENTO DI NEUROSCIENZE SALUTE MENTALE E ORGANI DI SENSO - NESMOS - SAPIENZA UNIVERSITÀ DI ROMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
34Phase 2United States;Italy

114. 非ジストロフィー性ミオトニー症候群


臨床試験数 : 12 薬物数 : 19 - (DrugBank : 5) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 10
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-002627-10-IT
(EUCTR)
03/11/201505/11/2020Pivotal study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A orCLCN1 genes.A randomized, double-blind, controlled, monocenter, pivotal phase IIb study to evaluate the efficacy and safety of riluzole versus mexiletine in patients with non dystrophic myotonia mutated in SCN4A or CLCN1 genes. - RILUMEX NDM patients with mutations in SCN4A or CLCN1 gene
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: RILUZOLO TEVA - 50 MG COMPRESSE RIVESTITE CON FILM 90 COMPRESSE IN BLISTER AL/PVC
Product Name: RILUZOLO
INN or Proposed INN: RILUZOLO
INN or Proposed INN: MEXILETINA CLORIDRATO
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2Italy