Evidence map›Paper›PMID 38806873›Full record

ArticleNeurology and therapy2024

Relative Bioavailability Study of Midazolam Intramuscularly Administered with the Needle-Free Auto-Injector ZENEO

Olivier Lacombe, Yannick Pletan, Jean-Marie Grouin, Aislinn Brennan, Olivier Giré

Registry-linked trialAbstract read
In one paragraph

Article in Neurology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05026567 (A Single Center, Single Dose, Open Label, Randomized, Four-period Crossover Study in Healthy Subjects to Describe and Compare the Plasma Pharmacokinetics of Midazolam After Intramuscular Injection as a Solution by a Conventional Syringe or by the Needle-free Injector ZENEO®), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT05026567 phase1completednot on this map

A Single Center, Single Dose, Open Label, Randomized, Four-period Crossover Study in Healthy Subjects to Describe and Compare the Plasma Pharmacokinetics of Midazolam After Intramuscular Injection as a Solution by a Conventional Syringe or by the Needle-free Injector ZENEO®

TypeinterventionalSponsorCrossjectRan2022 to 2022Enrolled40ConditionsHealthyArms2 ml of DORMICUM® Midazolam Hydrochloride (15 mg/3 mL), ZENEO® Midazolam (10 mg/0.625 mL) on bare skin in thigh, ZENEO® Midazolam (10 mg / 0.625 mL) on bare skin in ventrogluteal area, ZENEO® Midazolam (10 mg / 0.625 mL) through clothing in thigh
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Alternatives to Injectable Adrenaline for Treating Anaphylaxis.Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology · 2025
    Review
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

5 authors.

Olivier LacombeCROSSJECT SA, 6 rue Pauline Kergomard, 21000, Dijon, France. o.lacombe@crossject.com.ORCID http://orcid.org/0009-0001-9238-7702
Yannick PletanULTRace Development Partner, 30 Avenue Jean Jaurès, 91400, Orsay, France.
Jean-Marie GrouinUniversité de Rouen, 1 rue Thomas Becket, 76821, Mont-Saint-Aignan, France.
Aislinn BrennanICTA PM, 11 Rue du Bocage, 21121, Fontaine-lès-Dijon, France.
Olivier GiréCROSSJECT SA, 6 rue Pauline Kergomard, 21000, Dijon, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIntramuscular (IM) midazolam is indicated for the treatment of status epilepticus. Administration must be efficient to rapidly terminate prolonged seizures and prevent complications. The objective of this study was to compare, in terms of relative bioavailability and bioequivalence, IM midazolam injection by needle-free auto-injector, in different settings, to IM midazolam injection by a conventional syringe and needle.

methodsIn this open-label, randomized, four-period crossover study, healthy adults received single doses of midazolam (10 mg) under fasting conditions. The reference treatment (conventional syringe) was administered once, on bare skin in the thigh. The tested treatment (the needle-free auto-injector ZENEO

resultsForty adults were enrolled and included in the PK analysis set. In all comparisons, the 90% confidence interval (CI) of the least-squares geometric mean ratios for AUC DISCUSSION/

conclusionThis study establishes that IM midazolam injection on bare skin in the thigh with the ZENEO TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov identifier: NCT05026567. Registration first posted August 30, 2021, first patient enrolled May 9, 2022.

Indexed as

Auto-injectorEmergencyEpilepsyMidazolam

Identifiers

PMID38806873
PMCPMC11263531

What OpenQuestion holds

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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.