Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A 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 Syndrome

Trial Profile

A 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 Syndrome

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Jan 2023

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Fenfluramine (Primary)
  • Indications Dravet syndrome
  • Focus Registrational; Therapeutic Use
  • Sponsors Zogenix
  • Most Recent Events

    • 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.
    • 06 Dec 2022 Results of post-hoc, pooled analysis from two identical phase 3 clinical trials (NCT02682927, NCT02826863) using an alternative time-to-event (TTE) analysis of efficacy and focusing on the number of seizure-free days and the maximum duration of seizure-free intervals presented at the 76th Annual Meeting of the American Epilepsy Society
    • 21 Sep 2022 Status changed from active, no longer recruiting to completed.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top