Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 6 changes
notable Primary completion pushed: 2026-07-31 -> 2026-08-31 2026-08-01
minor Completion pushed: 2026-07-31 -> 2026-08-31 2026-08-01
notable Primary completion pushed: 2026-06-30 -> 2026-07-31 2026-07-02
minor Completion pushed: 2026-06-30 -> 2026-07-31 2026-07-02
notable Primary completion pushed: 2026-04 -> 2026-06-30 2026-05-20
minor Completion pushed: 2026-04 -> 2026-06-30 2026-05-20
Trial Details
NCT Number NCT05077904
Lead Sponsor UCB Biopharma SRL
Conditions Stereotypical Prolonged Seizures
Enrollment 350 participants
Start Date 2021-12-07
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-14