Zx008 - 0.2 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
140ドラベ症候群2

140. ドラベ症候群 [臨床試験数:83,薬物数:54(DrugBank:13),標的遺伝子数:48,標的パスウェイ数:62
Searched query = "Dorabe syndrome", "Dravet syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 83 trials found
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1NCT02926898
(ClinicalTrials.gov)
September 201610/8/2016A 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 SyndromeA 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 SyndromeDravet SyndromeDrug: ZX008 - 0.2 mg/kg/day;Drug: ZX008 - 0.4 mg/kg/day;Drug: ZX008 - 20 mg/day maximum dose;Drug: Matching PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLCompleted2 Years18 YearsAll105Phase 3United States;Canada;France;Germany;Netherlands;Spain;United Kingdom
2NCT02826863
(ClinicalTrials.gov)
July 15, 201613/6/2016A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet SyndromeA 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 SyndromeDravet SyndromeDrug: ZX008 - 0.8 mg/kg/day;Drug: ZX008 - 0.2 mg/kg/day;Drug: PlaceboZogenix International Limited, Inc., a subsidiary of Zogenix, Inc.NULLRecruiting2 Years18 YearsAll130Phase 3Australia;Belgium;Denmark;France;Germany;Italy;Japan;Spain;United Kingdom;Norway;Sweden