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
144	レノックス・ガストー症候群	1

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	NCT03355209 (ClinicalTrials.gov)	November 27, 2017	19/6/2017	A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome	A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS	Lennox Gastaut Syndrome	Drug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching Placebo	Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.	NULL	Recruiting	2 Years	35 Years	All	225	Phase 3	United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria

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

NCT03355209
(ClinicalTrials.gov)

November 27, 2017

19/6/2017

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

Lennox Gastaut Syndrome

Drug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching Placebo

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

NULL

Recruiting

2 Years

35 Years

All

225

Phase 3

United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria