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Clinical trial

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 (Cohort 1), 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 (Cohort 2)

NCT02926898 is registered in ClinicalTrials.gov with Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. as lead sponsor.

NCT NCT02926898
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Registry record

As filed in ClinicalTrials.gov.

Title
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 (Cohort 1), 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 (Cohort 2)
Lead sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Phase
Phase 3
Overall status
Completed
Start date
January 27, 2017
Completion date
June 5, 2018
Enrollment
87 (actual)
Sites
28

Conditions

As the registry lists them; a condition with its own page is linked.

dravet syndrome