A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects With Seizure Clusters

Trial Profile

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Intranasal Midazolam (USL261) in the Outpatient Treatment of Subjects With Seizure Clusters

Discontinued
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2018

At a glance

  • Drugs Midazolam (Primary)
  • Indications Generalised epilepsy; Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Acronyms ARTEMIS1
  • Sponsors Proximagen; Upsher-Smith
  • Most Recent Events

    • 20 Apr 2018 According to the UCB media release, NDA for Midazolam Nasal Spray will be filed in the course of 2018.
    • 05 Dec 2017 Results assessing safety and tolerability presented at the 71st Annual Meeting of the American Epilepsy Society
    • 05 Dec 2017 Results assessing efficacy presented at the 71st Annual Meeting of the American Epilepsy Society
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