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

A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stereotypical Prolonged Seizures

Interventions

Type	Name	Description
DRUG	Staccato alprazolam	Route of administration: Inhalation Participants will receive one dose of Staccato alprazolam during the Treatment Period.
OTHER	Placebo	Route of administration: Inhalation Participants will receive one dose of placebo during the Treatment Period.

Timeline

• Start date: 2021-12-07
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-10-14
• Last updated: 2026-04-13

Locations

182 sites across 13 countries: United States, Australia, Bulgaria, China, Czechia, France, Germany, Hungary, Italy, Japan, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study