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A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

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Trial Profile

A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2024

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At a glance

  • Drugs Fenfluramine (Primary)
  • Indications Drop attacks; Lennox-Gastaut syndrome; Seizures
  • Focus Registrational; Therapeutic Use
  • Sponsors Zogenix

    • Most Recent Events

    • 17 Apr 2024 According to a UCB media release, fenfluramine oral solution has been approved by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) as an add-on therapy to other anti-epileptic medicines for patients two years of age and older based upon this trial
    • 25 Sep 2023 Planned End Date changed from 13 Jan 2025 to 1 Jul 2024.
    • 25 Sep 2023 Planned primary completion date changed from 13 Jan 2025 to 1 Jul 2024.
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