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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jun 2023

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At a glance

  • Drugs Fenfluramine (Primary) ; Clobazam; Stiripentol; Valproic acid
  • Indications Dravet syndrome; Seizures
  • Focus Registrational; Therapeutic Use
  • Sponsors Zogenix
  • Most Recent Events

    • 20 Jun 2023 According to a UCB media release, company will share abstract of latest data from its epilepsy and rare epilepsy syndrome portfolio at the European Pediatric Neurology Society (EPNS) Annual Congress, June 20-24, 2023.
    • 01 Jan 2023 Results (n=61) assessing whether fenfluramine is associated with improvement in everyday executive function self-regulation-in preschool-aged children with Dravet syndrome from phase III studies (first study: placebo, FFA 0.2 mg/kg/day, or FFA 0.7 mg/kg/day added to stiripentol-free standard-of-care regimens; second study: placebo or FFA 0.4 mg/kg/day added to stiripentol-inclusive regimens), published in the Epilepsy and Behavior.
    • 22 Sep 2022 The number of treatment arms reduced from 4 to 2.
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