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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

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2023

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At a glance

  • Drugs Ganaxolone (Primary)
  • Indications Generalised seizures; Partial epilepsies; Seizures; Tonic-clonic epilepsy
  • Focus Registrational; Therapeutic Use
  • Acronyms MARIGOLD
  • Sponsors Marinus Pharmaceuticals

    • Most Recent Events

    • 20 Nov 2023 According to Marinus Pharmaceuticals media release, data from this study will be presented at the upcoming American Epilepsy Society (AES) 2023 Annual Meeting
    • 10 Nov 2023 Results from 2-year safety and clinical outcomes data from the open-label extension (OLE) phase of Marigold published in the Epilepsia
    • 31 Jul 2023 According to Orion Pharma media release, European Commission has granted marketing authorisation in the European Union (EU) for Ztalmy (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age
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