drugset / Trial / NCT05077904

A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

NCT05077904

Phase 3 Recruiting 350 enrolled UCB Biopharma SRL
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to assess the success of a single administration of Staccato alprazolam compared with placebo both in rapidly terminating a seizure episode within 90 seconds and with no recurrence of seizure(s) up to 2 hours after investigational medicinal product (IMP) administration.

Timeline

Start
2021-12-07
Primary completion
2026-07-31
Completion
2026-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Alprazolam Small molecule Inhaled

Indications