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A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed by Long-term Open-label Treatment

Trial Profile

A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults With Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed by Long-term Open-label Treatment

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2019

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At a glance

  • Drugs Ganaxolone (Primary)
  • Indications Seizures
  • Focus Registrational; Therapeutic Use
  • Acronyms MARIGOLD
  • Sponsors Marinus Pharmaceuticals
  • Most Recent Events

    • 08 Aug 2019 Planned number of patients changed from 70 to 100, as reported in a Marinus Pharmaceuticals media release. The Company remains on-track to report top-line data from this study in Q3 2020.
    • 11 Mar 2019 According to a Marinus Pharmaceuticals media release, In December the Company presented long-term data from the patients that entered the six-month open label extension of this study.
    • 19 Nov 2018 According to Marinus Pharmaceuticals media release,data from this study will be presented at the American Epilepsy Society (AES) Annual Meeting.
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