Trial reportEpilepsia2020
Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers.
Trial report in Epilepsia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.
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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 64 citations in OpenAlex.
- Pharmacokinetics and 180-day safety of diazepam nasal spray in pediatric patients with epilepsy aged 2-5 years.Epilepsia · 2025Trial
- Trial
- Trial
- Consistent safety and tolerability of ValtocoEpilepsia open · 2021Trial
- Trial
- Bioavailability and safety of diazepam intranasal solution compared to oral and rectal diazepam in healthy volunteers.Epilepsia · 2020Trial
- Efficacy and safety of diazepam nasal spray in Japanese Pediatric patients with or at risk for status epilepticus: a phase 3, Multicenter, open-label clinical trial.Epilepsy & behavior reports · 2026Article
- Drug-laced vaping-implications and emerging perioperative challenges for the anesthesiologist: a narrative review.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2026Review
- Analysis of the Correlation Between Membrane Permeability in RPMI 2650 Cells and Human Nasal Absorption.AAPS PharmSciTech · 2026Article
- Opportunities for and Challenges of Pulmonary Drug Delivery in the Management of Acute Exacerbations of CNS Disorders.CNS drugs · 2025Review
- Thermoreversible Ionogel for Enhanced Nose-to-brain Delivery of Tetrabenazine Hydrochloride: Optimization by Central Composite Design and In Vitro Ex Vivo Evaluation.AAPS PharmSciTech · 2025Article
- Exploring proposed recommendations for immediate-use seizure medication: Treating both cluster and prolonged seizures with diazepam nasal spray.Epilepsia open · 2025Review
- Olfactory Drug Delivery in Rodents: Deposition and Pharmacokinetics.ACS pharmacology & translational science · 2025Article
- Development of a novel dosing paradigm to model diazepam rescue therapy in preclinical seizure and epilepsy models.Epilepsia open · 2024Article
- Development ofPharmaceutics · 2024Review
- Opportunities for Community Pharmacists to Counsel Patients With Epilepsy and Seizure Clusters to Overcome Barriers and Foster Appropriate Treatment.Journal of pharmacy practice · 2024Review
- Benzodiazepines for the Treatment of Seizure Clusters.CNS drugs · 2024Review
- Diazepam nasal spray administration is effective to control seizure clusters irrespective of time of day.Frontiers in neurology · 2024Article
- Taking a Newer, Faster, Intranasal Route: A Narrative Review of Transitioning to a Less-Invasive Rescue Treatment for Seizure Clusters.Patient preference and adherence · 2024Review
- Practical Questions About Rescue Medications for Acute Treatment of Seizure Clusters in Children and Adolescents with Epilepsy in the USA: Expanding Treatment Options to Address Unmet Needs.Paediatric drugs · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 2 countries.
Funding
Abstract
objectiveThe study assesses the bioavailability of diazepam after intranasal administration (diazepam nasal spray) in healthy volunteers. Comparative agents were diazepam rectal gel, which served as the regulatory reference product; and oral diazepam, a product with decades of clinical use. Tolerability of diazepam nasal spray was also assessed.
methodsThis was a phase 1, open-label, randomized, single-dose, three-treatment, three-period, six-sequence crossover study in 48 healthy adult subjects that consisted of a screening period, a baseline period, and an open-label treatment period. Interperiod intervals were at least 28 days.
resultsForty-eight healthy volunteer subjects were enrolled, two of whom discontinued before receiving study medication. For all routes of administration, the onset of diazepam absorption was rapid, with measurable concentrations of drug present by the first sample time point. The t SIGNIFICANCE: Diazepam nasal spray shows predicable pharmacokinetics and represents a potential novel therapeutic approach to control bouts of increased seizure activity (cluster seizures, acute repetitive seizures).
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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.