Evidence map›Paper›PMID 41133403›Full record

ArticleEpilepsia2026

Pharmacokinetics and tolerability of single-dose Staccato® alprazolam in adolescents with epilepsy, and population pharmacokinetic analysis to support dose selection in adolescents.

Pavel Klein, Gewalin Aungaroon, Victor Biton, Kore Kai Liow, Steven Phillips, Thomas Wychowski, Ahmed Sadek, Jan-Peer Elshoff, Robert Roebling, Aliceson King and 3 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Epilepsia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04857307 (A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of Staccato Alprazolam in Adolescent Study Participants With Epilepsy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04857307 phase1completednot on this map

A Multicenter, Open-Label Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of a Single Dose of Staccato Alprazolam in Adolescent Study Participants With Epilepsy

TypeinterventionalSponsorUCB Biopharma SRLRan2021 to 2022Enrolled14ConditionsEpilepsyArmsAlprazolam
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Pavel KleinDepartment of Epilepsy, Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland, USA.
Gewalin AungaroonComprehensive Epilepsy Center, Division of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Victor BitonArkansas Epilepsy Program, Little Rock, Arkansas, USA.
Kore Kai LiowComprehensive Epilepsy Center, Hawaii Pacific Neuroscience, Honolulu, Hawaii, USA.
Steven PhillipsDepartment of Neurology, Mary Bridge Children's Hospital, MultiCare Institute for Research and Innovation, Tacoma, Washington, USA.
Thomas WychowskiDepartment of Neurology, University of Rochester Medical Center, Rochester, New York, USA.ORCID 0000-0003-1710-4888
Ahmed SadekResearch Institute of Orlando, Orlando, Florida, USA.
Jan-Peer ElshoffDepartment of Global Clinical Development, UCB, Monheim am Rhein, Germany.
Robert RoeblingDepartment of Global Clinical Development, UCB, Monheim am Rhein, Germany.
Aliceson KingDepartment of Safety Risk Management, UCB, Smyrna, Georgia, USA.
Chiara C RospoDepartment of Precision Medicine, UCB, Braine-l'Alleud, Belgium.
Rik SchoemakerOccams Coöperatie U.A., Amstelveen, The Netherlands.
Hugues ChanteuxDepartment of Early Clinical Development & Translational Sciences, Patient Solutions, UCB, Braine-l'Alleud, Belgium.ORCID 0000-0002-2222-9813

Funding

UCB
6 · The paper itself

Abstract

objectiveStaccato® alprazolam is a hand-held inhalation device that provides rapid systemic delivery of alprazolam through the intrapulmonary route. This trial explored the pharmacokinetics and tolerability of single-dose Staccato alprazolam 2 mg in adolescents with epilepsy. Pharmacokinetic data were included in a population pharmacokinetic analysis to support adolescent dose selection in the Phase 3 trials.

methodsMulticenter, Phase 1, open-label trial in adolescents (12-17 years) with focal, generalized, or focal and generalized epilepsy (UP0100/NCT04857307). A single dose of Staccato alprazolam 2 mg was administered in the morning following overnight fast. Pharmacokinetic data were used to update an existing population pharmacokinetic model in adults, which was used to investigate dosing in adolescents with epilepsy.

resultsFourteen patients (6 weighing <50 kg, 8 weighing ≥50 kg) were enrolled and administered Staccato alprazolam 2 mg. Individual plasma alprazolam concentration-time profiles indicated generally rapid absorption (median time to maximum plasma concentration [C SIGNIFICANCE: Alprazolam was rapidly absorbed in most adolescent patients with epilepsy following administration with the Staccato device. No clinically relevant differences between body weight groups were observed on primary pharmacokinetic or safety outcomes. Staccato alprazolam 2 mg was well tolerated. Overall, the present data support the use of Staccato alprazolam 2 mg in adolescents with epilepsy (12-17 years of age).

Indexed as

AlprazolamAnticonvulsantsEpilepsyAdministration, InhalationAdolescentChildDose-Response Relationship, DrugFemaleHumansMaleAlprazolamAnticonvulsantsantiseizure medicationinhaled alprazolamlung deliveryprolonged seizuresRapid and Early Seizure Termination

Identifiers

PMID41133403
PMCPMC12893244

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.