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NCT04857307 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy

A Phase 1 study, sponsored by UCB Biopharma SRL.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT04857307: Completed Phase 1 study, sponsored by UCB Biopharma SRL.

NCT04857307 is a Phase 1 study that has completed, run by UCB Biopharma SRL. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04857307, a Phase 1 study, has completed, sponsored by UCB Biopharma SRL.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.

Primary Outcome

Cmax = Maximum plasma concentration.

Interventions

  • DRUG Alprazolam

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2021-04-28
Est. Completion 2022-04-05
Phase Phase 1
UCB Biopharma SRL

82 total trials

What the finished NCT04857307 record still lists

NCT04857307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which Alprazolam is the first listed.

NCT04857307 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04857307 about?

NCT04857307 is a clinical study titled "A Study to Assess the Pharmacokinetics (PK) and Safety of Staccato Alprazolam in Adolescent Study Participants With Epilepsy". The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration.

What is the current status of trial NCT04857307?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2021-04-28. Estimated completion is 2022-04-05.

What interventions are being tested in trial NCT04857307?

The interventions under investigation include: Alprazolam (DRUG).

Who is sponsoring clinical trial NCT04857307?

This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04857307's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT04857307, the US trial registry maintained by the National Library of Medicine. NCT04857307 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.