DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
140	ドラベ症候群	2

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	NCT02926898 (ClinicalTrials.gov)	September 2016	10/8/2016	A Two-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children =2 Years Old and Young Adults With Dravet Syndrome	A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care , Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome	Dravet Syndrome	Drug: ZX008 - 0.2 mg/kg/day;Drug: ZX008 - 0.4 mg/kg/day;Drug: ZX008 - 20 mg/day maximum dose;Drug: Matching Placebo	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.	NULL	Completed	2 Years	18 Years	All	105	Phase 3	United States;Canada;France;Germany;Netherlands;Spain;United Kingdom
2	NCT02826863 (ClinicalTrials.gov)	July 15, 2016	13/6/2016	A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome	A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome	Dravet Syndrome	Drug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: Placebo	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.	NULL	Recruiting	2 Years	18 Years	All	130	Phase 3	Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden

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

NCT02926898
(ClinicalTrials.gov)

September 2016

10/8/2016

A Two-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children =2 Years Old and Young Adults With Dravet Syndrome

A Multicenter, 2-Cohort Trial to First Assess the Pharmacokinetic and Safety Profile of a Single Dose of ZX008 (Fenfluramine Hydrochloride) Oral Solution When Added to Standard of Care , Followed by a Randomized, Double-blind, Placebo-controlled Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of ZX008 as Adjunctive Antiepileptic Therapy to Stiripentol Treatment in Children and Young Adults With Dravet Syndrome

Dravet Syndrome

Drug: ZX008 - 0.2 mg/kg/day;Drug: ZX008 - 0.4 mg/kg/day;Drug: ZX008 - 20 mg/day maximum dose;Drug: Matching Placebo

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

NULL

Completed

2 Years

18 Years

All

105

Phase 3

United States;Canada;France;Germany;Netherlands;Spain;United Kingdom

NCT02826863
(ClinicalTrials.gov)

July 15, 2016

13/6/2016

A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

Dravet Syndrome

Drug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: Placebo

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

NULL

Recruiting

2 Years

18 Years

All

130

Phase 3

Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden