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A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus

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Trial Profile

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 17 May 2024

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At a glance

  • Drugs Ganaxolone (Primary) ; Antiepileptic drugs
  • Indications Status epilepticus
  • Focus Registrational; Therapeutic Use
  • Acronyms RAISE II
  • Sponsors Marinus Pharmaceuticals

    • Most Recent Events

    • 10 May 2024 Planned End Date changed from 1 Nov 2025 to 1 Aug 2024.
    • 10 May 2024 Planned primary completion date changed from 1 Nov 2025 to 1 Aug 2024.
    • 10 May 2024 Planned initiation date changed from 1 Feb 2024 to 1 Mar 2024.

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