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NCT05077904 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Stereotypical Prolonged Seizures, sponsored by UCB Biopharma SRL.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT05077904: Recruiting Phase 3 study of Stereotypical Prolonged Seizures, sponsored by UCB Biopharma SRL.
NCT05077904 is a Phase 3 study of Stereotypical Prolonged Seizures that is actively recruiting participants, run by UCB Biopharma SRL. The registered enrollment target is 350 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05077904, a Phase 3 study of Stereotypical Prolonged Seizures, is actively recruiting participants, sponsored by UCB Biopharma SRL.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Treatment success for the treated seizure is defined as termination of the seizure within 90 seconds after IMP administration.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Staccato alprazolam
Study Locations (20)
Florida
- Ep0162 50721 - Boca Raton
- Ep0162 50515 - Gulf Breeze
- Ep0162 50508 - Jacksonville
- Ep0162 50342 - Jacksonville
- Ep0162 50199 - Miami
- Ep0162 50676 - Miami
- Ep0162 50509 - Orlando
- Ep0162 50703 - Rockledge
California
- Ep0162 50118 - Downey
- Ep0162 50416 - La Jolla
- Ep0162 50702 - Long Beach
- Ep0162 50505 - Los Angeles
- Ep0162 50492 - Orange
- Ep0162 50722 - Poway
- Ep0162 50716 - Sacramento
Arizona
- Ep0162 50506 - Phoenix
- Ep0162 50720 - Scottsdale
Arkansas
- Ep0162 50494 - Little Rock
Connecticut
- Ep0162 50367 - New Haven
District of Columbia
- Ep0162 50088 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2021-12-07 |
| Est. Completion | 2026-04-06 |
| Phase | Phase 3 |
What NCT05077904 shows while recruiting
NCT05077904 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Stereotypical Prolonged Seizures appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05077904 names 20 study sites across 6 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05077904 about?
NCT05077904 is a clinical study titled "A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures". 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.
What is the current status of trial NCT05077904?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2021-12-07. Estimated completion is 2026-04-06.
What conditions does trial NCT05077904 study?
This clinical trial studies the following conditions: Stereotypical Prolonged Seizures.
What interventions are being tested in trial NCT05077904?
The interventions under investigation include: Placebo (OTHER), Staccato alprazolam (DRUG).
Who is sponsoring clinical trial NCT05077904?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05077904 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05077904's enrollment target sits among peer trials
350 1035th of 2000 higher than 956 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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