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Multiple ascending dose study of a second generation ganaxolone formulation

Trial Profile

Multiple ascending dose study of a second generation ganaxolone formulation

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 26 Apr 2025

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At a glance

  • Drugs Ganaxolone (Primary)
  • Indications Lennox-Gastaut syndrome
  • Focus Adverse reactions
  • Acronyms MAD study

Most Recent Events

  • 16 Aug 2023 Status changed to recruiting, according to a Marinus Pharmaceuticals media release.
  • 11 May 2023 According to a Marinus Pharmaceuticals media release, pending FDA feedback and agreement, trial is now expected to initiate in the third quarter of 2023 with preliminary data expected by year end 2023. The company is Planning to finalize clinical program design for Lennox-Gastaut syndrome in the first quarter of 2024, pending results of this trial.
  • 22 Mar 2023 According to a Marinus Pharmaceuticals media release, the company expects to initiate this trial in the second quarter of 2023 and is planning to finalize the clinical program design for LGS in the second half of this year.

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