The Winner by a Nose: Intranasal Midazolam.

The Winner by a Nose: Intranasal Midazolam.
Epilepsy Curr. 2019 Aug 28;:1535759719870508
Authors: Faught E
Abstract
Safety and Efficacy of Midazolam Nasal Spray in the Outpatient Treatment of Patients With Seizure Clusters-A Randomized, Double-Blind, Placebo-Controlled Trial. Detyniecki K, Van Ess PJ, Sequeira DJ, Wheless JW, Meng TC, Pullmnaan WE. Epilepsia. 2019. doi:10.1111/epi.15159. Epub ahead of print.
OBJECTIVE: To evaluate the safety and efficacy of a novel formulation of midazolam administered as a single-dose nasal spray (MDZ-NS) in the outpatient treatment of patients experiencing seizure clusters (SCs).
METHODS: This was a phase III, randomized, double-blind, placebo-controlled trial ( ClinicalTrials.gov NCT01390220) with patients aged ≥12 years on a stable regimen of antiepileptic drugs. Following an in-clinic test dose phase (TDP), patients entered an outpatient comparative phase (CP) and were randomized (2:1) to receive double-blind MDZ-NS 5 mg or placebo nasal spray, administered by caregivers when they experienced an SC. The primary efficacy end point was treatment success (seizure termination within 10 minutes and no recurrence 10 minutes to 6 hours after trial drug administration). Secondary efficacy end points were proportion of patients with seizure recurrence 10 minutes to 4 hours and time to next seizure >10 minutes after double-blind drug administration. Safety was monitored throughout.
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Source: Epilepsy Currents - August 29, 2019 Category: Neurology Tags: Epilepsy Curr Source Type: research