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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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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: 23 Aug 2024

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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

    • 21 Aug 2024 According to a Medicines and Healthcare products Regulatory Agency (MHRA) media release, MHRA has (7 March 2024) approved the medicine ganaxolone (Ztalmy) as the first anti-seizure medication in the UK to treat cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD). This approval is supported by evidence from a phase 3 randomised, double-blind, placebo-controlled clinical trial involving 101 patients with CDD aged 2 to 19 years.
    • 18 Jul 2024 According to a Marinus Pharmaceuticals media release, company announced that the China National Medical Products Administration (NMPA) has approved ganaxolone oral suspension for the treatment of epileptic seizures in patients two years of age and older with CDKL5 deciency disorder (CDD), supported by data from Phase 3 Marigold trial in CDD.
    • 01 Jul 2024 Results assessing Effects of ganaxolone on non-seizure outcomes in CDKL5 Deficiency Disorder published in the European Journal of Paediatric Neurology

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