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
Phase of Trial: Phase III
Latest Information Update: 25 Sep 2017
At a glance
- Drugs Midazolam (Primary)
- Indications Generalised epilepsy; Partial epilepsies
- Focus Registrational; Therapeutic Use
- Acronyms ARTEMIS1
- Sponsors Proximagen; Upsher-Smith
- 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.