Evidence map›Paper›PMID 42171659›Full record

ArticleEpilepsia2026

Clinical validation of a patient-friendly saliva microsampling approach to monitor perampanel levels in people with epilepsy.

Valentina Franco, Francesca Dattrino, Michela Palmisani, Federica Tacchella, Elena Tartara, Valentina De Giorgis, Carlo Alberto Quaranta, Ludovica Pasca, Paola Rota, Emilio Russo and 5 more

Abstract readValidation Study
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. 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

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

15 authors.

Valentina FrancoDepartment of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0003-4736-4437
Francesca DattrinoDepartment of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0009-0000-3794-1363
Michela PalmisaniDepartment of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0009-0005-7155-9447
Federica TacchellaIRCCS Mondino Foundation, Pavia, Italy.ORCID https://orcid.org/0009-0008-5305-9598
Elena TartaraIRCCS Mondino Foundation, full member of European Reference Network EpiCARE, Pavia, Italy.ORCID https://orcid.org/0000-0003-1656-5420
Valentina De GiorgisDepartment of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0002-5828-7070
Carlo Alberto QuarantaChild Neurology and Psychiatry Unit, IRCCS Mondino Foundation, full member of European Reference Network EpiCARE, Pavia, Italy.ORCID https://orcid.org/0000-0002-2076-8848
Ludovica PascaDepartment of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.ORCID https://orcid.org/0000-0003-4382-0095
Paola RotaDepartment of Biomedical, Surgical, and Dental Sciences, University of Milan, Milan, Italy.ORCID https://orcid.org/0000-0001-5795-4989
Emilio RussoCRUISE Research Center, Science of Health Department, Magna Græcia University, Catanzaro, Italy.ORCID https://orcid.org/0000-0002-1279-8123
Andrea RomigiIRCCS Neuromed Mediterranean Neurological Institute, Sleep Medicine Center, Pozzilli, Italy.ORCID https://orcid.org/0000-0002-4505-2600
Cecilie Johannessen LandmarkProgram for Pharmacy, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.ORCID https://orcid.org/0000-0002-0877-8912
Guido FedeleAssociazione Farmaceutici dell'Industria, Milan, Italy.
Cristina TassorelliIRCCS Mondino Foundation, Pavia, Italy.ORCID https://orcid.org/0000-0003-1513-2113
Pierluigi NicoteraIRCCS Mondino Foundation, Pavia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Perampanel (PER) is a third-generation antiseizure medication (ASM) with a well-established concentration-effect relationship. Saliva represents a non-invasive alternative to plasma for therapeutic drug monitoring (TDM) of PER, as it reflects the free plasma fraction. Volumetric absorptive microsampling (VAMS) enables standardized, patient-friendly saliva collection. This study aimed to clinically validate saliva-VAMS by directly comparing it with conventional liquid saliva sampling for PER quantification. In a prospective study, saliva was collected from 11 people with epilepsy receiving PER therapy (dose range = 2-10 mg/day) using both VAMS and conventional saliva sampling. PER concentrations were measured by liquid chromatography coupled with tandem mass spectrometry and compared using repeated measures Bland-Altman analysis and Lin's concordance correlation coefficient to evaluate agreement between methods. PER concentrations measured in saliva-VAMS showed excellent agreement with those obtained from conventional saliva sampling, with mean bias of -0.126 ng/mL (95% confidence interval = -0.582 to 0.330). No relevant constant or proportional bias was observed, and limits of agreement were within predefined acceptance criteria. Concordance between methods was high, supporting analytical equivalence. The demonstrated interchangeability between saliva-VAMS and conventional saliva sampling supports adoption of saliva-VAMS in clinical TDM workflows, enabling standardized fixed-volume collection, simplified storage/transport, and potential home-based sampling for remote dose optimization of PER and potentially other ASMs.

Indexed as

AnticonvulsantsDrug MonitoringEpilepsyPyridonesSalivaSpecimen HandlingAdultChromatography, LiquidFemaleHumansMaleMiddle AgedNitrilesProspective StudiesTandem Mass SpectrometryYoung AdultAnticonvulsantsNitrilesperampanelPyridonesmicrosamplingperampanelsalivatherapeutic drug monitoring

Identifiers

PMID42171659
PMCPMC13361040

What OpenQuestion holds

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Registered trials

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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.