Ganaxolone, SPT3162, MD 9150000, CCD-1042, Mepalon 1042, (3a-hydroxy-3ß-methyl-5a-pregnan-20-one) ( DrugBank: Ganaxolone )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
152PCDH19関連症候群1

152. PCDH19関連症候群


臨床試験数 : 10 薬物数 : 7 - (DrugBank : 1) / 標的遺伝子数 : 16 - 標的パスウェイ数 : 7
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001324-36-IT
(EUCTR)
05/06/201516/04/2015Pilot, multicenter study to evaluate the efficacy of the ganaxolone in female children with PCDH19 Pediatric Epilepsy.A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children with PCDH19 Female Pediatric Epilepsy PCDH19 Female Pediatric Epilepsy (FPE)
MedDRA version: 18.0;Level: LLT;Classification code 10032062;Term: Other forms of epilepsy, with intractable epilepsy;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ganaxolone
Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316
INN or Proposed INN: GANAXOLONE
Other descriptive name: Ganaxolone, SPT3162, MD 9150000, CCD-1042, Mepalon 1042, (3a-hydroxy-3ß-methyl-5a-pregnan-20-one)
Product Name: ganaxolone
Product Code: CCD 1042
INN or Proposed INN: GANAXOLONE
Other descriptive name: Ganaxolone, SPT3162, MD 9150000, CCD-1042, Mepalon 1042, (3a-hydroxy-3ß-methyl-5a-pregnan-20-one)
Marinus Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
10United States;Italy