152. ＰＣＤＨ19関連症候群 PCDH19 related syndrome Clinical trials / Disease details

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

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No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-004496-12-GB (EUCTR)	14/01/2020	18/11/2019	A clinical study with an investigational drug called ganaxolone in female children with protocadheri ...	A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female ch ...	protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ...	Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ...	Marinus Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	70	Phase 3	United States;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Den ...
2	EUCTR2018-004496-12-HU (EUCTR)	13/01/2020	04/11/2019	A clinical study with an investigational drug called ganaxolone in female children with protocadheri ...	A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female ch ...	protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ...	Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ...	Marinus Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	70	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ...	United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Austral ...
3	EUCTR2018-004496-12-FR (EUCTR)	26/09/2019	29/04/2019	A clinical study with an investigational drug called ganaxolone in female children with protocadheri ...	A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female ch ...	protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ...	Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: ...	Marinus Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	50	Phase 3	United States;France;Hungary;Poland;Spain;Australia;Netherlands;Italy;United Kingdom
4	EUCTR2018-004496-12-NL (EUCTR)	23/09/2019	05/06/2019	A clinical study with an investigational drug called ganaxolone in female children with protocadheri ...	A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female ch ...	protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ...	Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ...	Marinus Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	30	Phase 2	United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Belgium;Poland;Australia;Denm ...
5	EUCTR2018-004496-12-IT (EUCTR)	26/06/2019	20/01/2021	A clinical study with an investigational drug called ganaxolone in female children with protocadheri ...	A double-blind, randomized, placebo-controlled trial of adjunctiveganaxolone treatment in female chi ...	protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ...	Product Name: Ganaxolone Product Code: [CCD 1042, MD 9150000, Mepalon 1042, SPT316] INN or Proposed IN ...	Marinus Pharmaceuticals, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	70	Phase 3	United States;Czechia;Israel;Italy;United Kingdom;France;Hungary;Belgium;Poland;Australia;Denmark;Ge ...
6	NCT03865732 (ClinicalTrials.gov)	May 17, 2019	5/3/2019	Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related E ...	A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Female Ch ...	PCDH19-Related Epilepsy	Drug: Ganaxolone;Drug: Placebo	Marinus Pharmaceuticals	NULL	Active, not recruiting	1 Year	17 Years	Female	25	Phase 2	United States;Hungary;Italy;Netherlands;Poland;Australia;France
7	EUCTR2015-001324-36-IT (EUCTR)	05/06/2015	16/04/2015	Pilot, multicenter study to evaluate the efficacy of the ganaxolone in female children with PCDH19 P ...	A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children with PCDH19 Female Pediat ...	PCDH19 Female Pediatric Epilepsy(FPE) MedDRA version: 18.0;Level: LLT;Classification code 10032062;T ...	Product Name: ganaxolone Product Code: CCD 1042 , MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: ...	Marinus Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: no	10		United States;Italy
8	NCT02358538 (ClinicalTrials.gov)	March 2015	30/1/2015	A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediat ...	A Multicenter, Open-Label Proof-of-Concept Trial of Ganaxolone in Children With PCDH19 Female Pediat ...	Epilepsy	Drug: Ganaxolone	Marinus Pharmaceuticals	NULL	Active, not recruiting	2 Years	18 Years	All	30	Phase 2	United States;Italy
9	EUCTR2018-004496-12-DK (EUCTR)		07/11/2019	A clinical study with an investigational drug called ganaxolone in female children with protocadheri ...	A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female ch ...	protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ...	Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT316 INN or Proposed INN: ...	Marinus Pharmaceuticals, Inc.	NULL	NA			Female: yes Male: no	70	Phase 3	United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark ...
10	EUCTR2018-004496-12-PL (EUCTR)		01/08/2019	A clinical study with an investigational drug called ganaxolone in female children with protocadheri ...	A double-blind, randomized, placebo-controlled trial of adjunctive ganaxolone treatment in female ch ...	protocadherin 19 (PCDH19)-related epilepsy MedDRA version: 20.0;Level: LLT;Classification code 10032 ...	Product Name: Ganaxolone Product Code: CCD 1042, MD 9150000, Mepalon 1042, SPT3162 INN or Proposed INN ...	Marinus Pharmaceuticals, Inc.	NULL	NA			Female: yes Male: no	30	Phase 2	United States;Czechia;Spain;Ireland;Italy;United Kingdom;France;Hungary;Poland;Belgium;Australia;Den ...

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