M071754 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
145ウエスト症候群4

145. ウエスト症候群


臨床試験数 : 43 薬物数 : 52 - (DrugBank : 15) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 26
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-142559
01/11/201202/06/2014A open-label study of M071754 in patients with infantile spasmsA Long term study of M071754 - A open-label study in patients with infantile spasms - infantile spasmsIntervention name : M071754
INN of the intervention : vigabatrin
Dosage And administration of the intervention : oral
Alfresa Pharma CorporationSanofi KK05BOTHPhase 4NULL
2JPRN-JapicCTI-142558
01/8/2012A single-blind study of M071754 in patients with infantile spasmsA Phase III study of M071754 - A single-blind study in patients with infantile spasms - infantile spasmsIntervention name : M071754
INN of the intervention : vigabatrin
Dosage And administration of the intervention : oral
Control intervention name : null
Alfresa Pharma CorporationSanofi KK01BOTH12Phase 3NULL
3EUCTR2017-000230-62-Outside-EU/EEA
(EUCTR)
24/04/2017A single-blind study of M071754 in patients with infantile spasms.A Phase III study of M071754 - A single-blind study in patients with infantile spasms. - Patients diagnosed with infantile spasms
MedDRA version: 19.1;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VIGABATRIN
Product Code: M071754
INN or Proposed INN: VIGABATRIN
Alfresa Pharma Corporation and Sanofi KKNULLNAFemale: yes
Male: yes
12Phase 3Japan
4EUCTR2017-000611-17-Outside-EU/EEA
(EUCTR)
28/08/2017A open-label study of M071754 in patients with infantile spasms.A Long term study of M071754 - A open-label study in patients with infantile spasms. Patients diagnosed with infantile spasms
MedDRA version: 20.0;Level: PT;Classification code 10021750;Term: Infantile spasms;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: VIGABATRIN
Product Code: M071754
INN or Proposed INN: VIGABATRIN
Alfresa Pharma Corporation and Sanofi KKNULLNAFemale: yes
Male: yes
17Phase 3Japan