Decision: Favourable

Decisions Table

Study Title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Multicenter Study to Examine the Efficacy and Safety of ZX008 in Subjects with CDKL5 Deficiency Disorder Followed by an Open-Label Extension

  • NREC Code:

    22-NREC-CT-144

  • Decision:

    Favourable

  • Meeting Date:

    07/09/2022

  • Study Type:

    CT application

  • Principal Investigator:

    Dr. Kathleen Gorman

  • PI Institution:

    Children's Health Ireland at Temple Street

  • Sponsor:

    Zogenix International Limited

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