ZX008 - 20 mg/day maximum dose ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
140Dorabe syndrome1

140. Dorabe syndrome


Clinical trials : 104 Drugs : 61 - (DrugBank : 14) / Drug target genes : 48 - Drug target pathways : 63
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agemin
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PhaseCountries
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