ZX008 0.2 or 0.8 mg/kg/day ( DrugBank: - )


1 disease
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

144. レノックス・ガストー症候群


臨床試験数 : 111 薬物数 : 72 - (DrugBank : 14) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 61
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03355209
(ClinicalTrials.gov)
November 27, 201719/6/2017A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut SyndromeA 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 LGSLennox Gastaut SyndromeDrug: ZX008 0.2 or 0.8 mg/kg/day;Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLActive, not recruiting2 Years35 YearsAll296Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Poland;Spain;Sweden;Austria