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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 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05077904
The ClinicalTrials.gov registry entry for NCT05077904 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Biopharma SRL, which has 116 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05077904 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05077904?
The interventions under investigation include: Placebo (OTHER), Staccato alprazolam (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05077904?
This trial is sponsored by UCB Biopharma SRL, which has 116 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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