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 152. PCDH19関連症候群 [臨床試験数:3,薬物数:5(DrugBank:1),標的遺伝子数:16,標的パスウェイ数:7] 

Searched query = "PCDH19 related syndrome", "PCDH19 Epilepsy", "Epilepsy and mental retardation limited to females", "PCDH19 female pediatric epilepsy", "PCDH19-related epilepsy", "Protocadherin 19 (PCDH19)-related epilepsy"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03865732May 17, 201911 November 2019Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy Followed by Long-term Open-label Treatment.PCDH19-Related EpilepsyDrug: Ganaxolone;Drug: PlaceboMarinus PharmaceuticalsRecruiting1 Year17 YearsFemale70Phase 3United States;Australia;France;Italy
2EUCTR2015-001324-36-IT05/06/201510 July 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 EpilepsyPCDH19 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
Pharmaceutical Form: Oral suspension
INN or Proposed INN: GANAXOLONE
CAS Number: 38398-32-2
Current Sponsor code: CCD 1042
Other descriptive name: Ganaxolone, SPT3162, MD 9150000, CCD-1042, Mepalon 1042, (3a-hydroxy-3ß-methyl-5a-pregnan-20-one)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Product Name: ganaxolone
Product Code: CCD 1042
Pharmaceutical Form: Capsule
INN or Proposed INN: GANAXOLONE
CAS Number: 38398-32-2
Current Sponsor code: CCD 1042
Other descriptive name: Ganaxolone, SPT3162, MD 9150000, CCD-1042, Mepalon 1042, (3a-hydroxy-3ß-methyl-5a-pregnan-20-one)
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 200-225
Marinus Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: no
10United States;Italy
3NCT02358538March 201515 July 2019A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic EpilepsiesA Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies Followed by 52 Week Open-Label TreatmentEpilepsyDrug: GanaxoloneMarinus PharmaceuticalsNot recruiting2 Years18 YearsAll30Phase 2United States;Italy