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: 22 Jul 2017

At a glance

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

    • 26 Apr 2017 Based on the results of this trial, Proximagen will approach the US FDA regarding its proposal to submit a 505(b)(2) New Drug Application (NDA) in the second half of this year. Findings from the trial will be presented at the upcoming Antiepileptic Drug and Device Trials (AEDD) meeting, according to a company media release.
    • 26 Apr 2017 Primary endpoint (Proportion of subjects who meet the criteria for Treatment Success.) has been met, according to a Proximagen media release.
    • 24 Apr 2017 Status changed from recruiting to discontinued.
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