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A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Multiple-Center, Efficacy and Safety Study of ZYN002 Administered as a Transdermal Gel to Children and Adolescents With Fragile X Syndrome

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 06 Nov 2019

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At a glance

  • Drugs Cannabidiol (Primary)
  • Indications Fragile X syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms CONNECT-FX
  • Sponsors Zynerba Pharmaceuticals
  • Most Recent Events

    • 06 Nov 2019 According to a Zynerba Pharmaceuticals media release, the company expects to report topline results from the study, in the first half of 2020. If the results are positive, the Company expects to submit its New Drug Application (NDA) for Zygel in Fragile-X-syndrome (FXS) to the U.S. Food and Drug Administration (FDA) in the second half of 2020.
    • 26 Feb 2019 According to a Zynerba Pharmaceuticals media release, Based on the result of this study, the US patent and Trademark Office has issued US Patent, as the enrollment progresses in this study.
    • 09 Jul 2018 According to a Zynerba Pharmaceuticals media release, based on discussions with the U.S. FDA, the Company will anchor the CGI-I scale to behavioral symptoms of FXS.
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