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A Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Midazolam Intranasal Spray (USL261) for the Treatment of Intermittent Bouts of Increased Seizure Activity in the Epilepsy Monitoring Unit (EMU)

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A Randomized, Double-Blind, Placebo Controlled Trial Examining the Safety and Efficacy of Midazolam Intranasal Spray (USL261) for the Treatment of Intermittent Bouts of Increased Seizure Activity in the Epilepsy Monitoring Unit (EMU)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2020

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At a glance

  • Drugs Midazolam (Primary)
  • Indications Generalised seizures; Seizures
  • Focus Registrational; Therapeutic Use
  • Acronyms ARTEMIS EMU
  • Sponsors UCB; Upsher-Smith

    • Most Recent Events

    • 02 Nov 2020 Results published in the Epilepsia.
    • 05 Dec 2017 Primary endpoint (Proportion of subjects that are seizure-free) has not been met as per the results presented at the 71st Annual Meeting of the American Epilepsy Society
    • 05 Dec 2017 Results assessing safety and efficacy presented at the 71st Annual Meeting of the American Epilepsy Society

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